MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-20 for VITROS IMMUNODIAGNOSTICS PRODUCTS MYOGLOBIN REAGENT PACK 6801042 manufactured by Ortho-clinical Diagnostics.
[114944903]
The investigation determined that a lower than expected myoglobin result was obtained from a level 1 biorad quality control fluid processed using vitros myoglobin reagent on a vitros eciq immunodiagnostic system. A definitive assignable cause for the event could not be determined with the information provided by the customer. Based on historical quality control results, a vitros myog lot 1315 performance issue is not a likely contributor to the event. Additionally, there is also no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the events as precision testing performed on the instrument was within ortho guidelines. The mdr is being submitted after the 30 day reporting date due to a technical issue with ortho? S mdr reporting system. Ortho was unable to electronically submit mdrs from 5 july 2018? 19 july 2018.
Patient Sequence No: 1, Text Type: N, H10
[114944904]
The customer obtained a lower than expected myoglobin result from a non-vitros biorad level 1 quality control fluid processed using vitros immunodiagnostics products myoglobin (myog) reagent in combination a vitros eciq immunodiagnostic system. Biorad lot 29871 level 1 = 58. 1 ng/ml versus expected 70. 3 ng/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The unexpected vitros myoglobin results were generated from non-patient fluids, however the investigation cannot conclude that patient sample results were not affected and would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of the event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007111389-2018-00103 |
| MDR Report Key | 7707154 |
| Date Received | 2018-07-20 |
| Date of Report | 2018-07-20 |
| Date of Event | 2018-06-14 |
| Date Mfgr Received | 2018-06-14 |
| Device Manufacturer Date | 2018-03-09 |
| Date Added to Maude | 2018-07-20 |
| 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. JAMES A STEVENS |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal | 14626 |
| Manufacturer Phone | 5854533000 |
| Manufacturer G1 | ORTHO CLINICAL DIAGNOSTICS |
| Manufacturer Street | FELINDRE MEADOWS PENCOED |
| Manufacturer City | BRIDGEND, WALES CF355PZ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF35 5PZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS IMMUNODIAGNOSTICS PRODUCTS MYOGLOBIN REAGENT PACK |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | DDR |
| Date Received | 2018-07-20 |
| Catalog Number | 6801042 |
| Lot Number | 1315 |
| Device Expiration Date | 2018-12-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORTHO-CLINICAL DIAGNOSTICS |
| Manufacturer Address | 100 INDIGO CREEK DRIVE ROCHESTER NY 14626 US 14626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-20 |