MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-29 for VITROS CHEMISTRY PRODUCTS VALP REAGENT 6801709 manufactured by Ortho-clinical Diagnostics.
[89634008]
The investigation determined that lower than expected vitros valp quality control results were obtained on a vitros 5600 integrated system. A definitive assignable cause for the event was not identified. Although the historical quality control results were lower than expected when compared to the customer? S established baseline mean and the other vitros valp reagent lot, the results were consistent with the vitros peer data for the biorad fluid, and with standard deviation comparable to both established and peer values. Therefore, the vitros valp reagent did not likely contribute to the event, but cannot be completely ruled out. Although no precision test to assess the performance of the vitros 5600 system was completed, the precision of the historical qc results is consistent across two reagent lots, and over a period of time greater than 30 days, including the day the event was first observed. This indicates the vitros instrument is not a likely contributing factor to the event. The assignable cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10
[89634009]
The customer obtained lower than expected vitros valp quality control results using l3 of non-vitros biorad control, lot 46580, on a vitros 5600 integrated system. Br l3 vitros valp results 87. 5 and 90. 6 ug/ml versus expected 115. 3 ug/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected. The customer stated that no patient samples were in question for vitros valp over the time frame of the event, however, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b))(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2017-00016 |
| MDR Report Key | 6904082 |
| Date Received | 2017-09-29 |
| Date of Report | 2019-01-04 |
| Date of Event | 2017-09-04 |
| Date Mfgr Received | 2017-09-04 |
| Device Manufacturer Date | 2016-10-31 |
| Date Added to Maude | 2017-09-29 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | 1000 LEE ROAD |
| Manufacturer City | ROCHESTER NY 14606 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14606 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS VALP REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | LEG |
| Date Received | 2017-09-29 |
| Catalog Number | 6801709 |
| Lot Number | 2511-25-5727 |
| ID Number | 10758750006748 |
| Device Expiration Date | 2018-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-09-29 |