MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-08-31 for VIDAS? TSH ASSAY 30400-01 manufactured by Biomerieux Sa.
[24586642]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[24586643]
On 06. 08. 2015 a usa customer reported tsh results as immeasurable using ref. (b)(4), vidas tsh 60 tests. Customer ran several other assays which came out as expected. There is no indication or report from the hospital or treating physician to biomerieux that the discrepant vidas tsh results led to any adverse event related to the patient's state of health. Recurrence of the event may potentially cause or contribute to an adverse event..
Patient Sequence No: 1, Text Type: D, B5
[35373471]
Internal investigation was conducted. Review of the quality product laboratory batch records indicates vidas? Tsh batch 160226-0/1003835280 passed all performance testing; no anomalies were cited. This lot performed in accordance with specifications. The customer submittals (3) were tested via the following methods: vidas? Tsh, vidas? Tsh3, vidas? Ft4, cobas tsh/roche. The results of all methods consistently indicate hyperthyro? Dism; the inconsistent results obtained by the customer are not reproduced/confirmed. The vidas? Tsh ref. (b)(4) batch 1003835280/160223-0 is performing within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00077 |
| MDR Report Key | 5041657 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-08-31 |
| Date of Report | 2015-08-06 |
| Date of Event | 2015-08-06 |
| Device Manufacturer Date | 2015-03-11 |
| Date Added to Maude | 2015-08-31 |
| 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 | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| 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? TSH ASSAY |
| Generic Name | VIDAS? TSH ASSAY |
| Product Code | LYR |
| Date Received | 2015-08-31 |
| Catalog Number | 30400-01 |
| Lot Number | 1003835280 |
| Device Expiration Date | 2016-02-26 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2015-08-31 |