MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-12-28 for VIDAS? LYME IGM 30319 manufactured by Biomerieux Sa.
[63615907]
A customer in (b)(6) reported to biom? Rieux a false negative result in association with the vidas? Lyme igm test for a (b)(6) patient with heart problems, whereas the doctor suspected borreliosis. The results were: vidas? Lyme igm - negative (tv 0,05), vidas? Lyme igg - negative ( tv 0,01). In addition, a western blot (wb) lyme igm test was performed. The result of the wb igm was positive with strong positive reaction for the ospc and p41 bands, and weak positive reaction ospc bb. The physician and patient were informed about both results (negative vidas? Tests and positive wb test). There is no indication or report that the discrepant result led to any adverse event related to the patient's state of health. An internal biom? Rieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[73721779]
An internal biom? Rieux investigation concluded the following: this complaint is related to a negative result vidas lyme igm lot 1005181000/170906-0 while the result is positive with western blot test (euroimmun). There is no other complaint registered on the vidas lyme igm lot 1005181000/170906-0 for sensitivity issue. There are no capa and nor non conformity for vidas lyme igm 1005181000/170906-0 linked to this complaint. The analysis of the batch history records shows no anomaly during the manufacturing and control process. The analysis of the control card of vidas lyme igm lot 1005181000/170906-0 shows that there is no significant variation for this lot compared to the other lots. On january 20th, the product quality laboratory tested five internal samples on the retain kit vidas lyme igm batch 1005181000/170906-0 on vidas pc, the results obtained are similar to the results obtained during the release of the batch. On february 10th, the product quality laboratory tested two return customer's samples (sampling of (b)(6) 2016 and sampling (b)(6) 2017) on the retain kit vidas lyme igm lot 1005181000/170906-0 and retain kit vidas lyme igg lot1005160750/170906-0 as the customer done. The results obtained for the 2 samples tested for vidas lyme igm lot 1005181000/170906-0 are negative and negative with vidas lyme igg lot 1005160750/170906-0. We reproduced the customer's result. The product quality laboratory tested the 2 samples with lymecheck igm /igg (western blot technique), the results obtained are negative for the 2 samples. We obtained a p41 band but it is not specific band for lyme. The results found on lymecheck igm is in agreement with the results found on the vidas lyme igm batch 1005181000 / 170906-0. The 2 samples sent to an external laboratory and they tested another lia technique (diasorin) and another western blot technique : mikrogen the results found on immunoblot-mikrogen are negative and in accordance with vidas results. The results found with lia method are found equivocal or low positive. The investigation showed that for the 2 samples return, the results are negatives with vidas lyme igm lot 1005181000/170906-0 as the 2 western blot techniques tested mikrogen and lymecheck. The performance of vidas lyme igm lot 1005181000/170906-0 are within expected specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00532 |
| MDR Report Key | 6210729 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-28 |
| Date of Report | 2017-04-07 |
| Date Mfgr Received | 2017-03-15 |
| Date Added to Maude | 2016-12-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS? LYME IGM |
| Generic Name | VIDAS? LYME IGM |
| Product Code | LYR |
| Date Received | 2016-12-28 |
| Catalog Number | 30319 |
| Lot Number | 1005181000 |
| Device Expiration Date | 2017-09-06 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-28 |