MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-30 for VITROS CHEMISTRY PRODUCTS VALP REAGENT 6801710 manufactured by Ortho-clinical Diagnostics.
[119649453]
The investigation determined that a lower than expected vitros valp result was obtained from a patient sample processed as part of a valp lot to lot correlation using a vitros 5600 integrated system. The definitive assignable cause of this event could not be determined. However, a possible contributor to the event was suspected to be calibration to calibration variability. There was no indication of a performance issue with either valp lot (2511-25-6393 and 2511-26-6711) based on qc performance; however, the accuracy of results obtained using valp lot 2511-25-6393 was lower than the accuracy of results obtained using valp lot 2511-26-6711 as shown with the patient correlation results. Continual tracking and trending of complaints has not identified any signals that would indicate a potential systemic issue with either of the vitros valp reagent lots. An instrument related issue is not a likely cause of the event as the two vitros 5600 systems generated reproducible results.
Patient Sequence No: 1, Text Type: N, H10
[119649454]
The customer obtained a lower than expected vitros valp result (66. 41 ug/ml versus expected 83. 17, 83. 53, 86. 31 ug/ml) from a patient sample processed using the vitros 5600 integrated system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected. The patient sample result in question was obtained as part of valp lot to lot correlation study and therefore, no patient results were reported outside the laboratory. There was no reported 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 | 1319808-2018-00024 |
| MDR Report Key | 7834697 |
| Date Received | 2018-08-30 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-08-02 |
| Date Mfgr Received | 2018-08-03 |
| Device Manufacturer Date | 2017-10-05 |
| Date Added to Maude | 2018-08-30 |
| 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 | 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 DIAGNOSTICS |
| Product Code | LEG |
| Date Received | 2018-08-30 |
| Catalog Number | 6801710 |
| Lot Number | 2511-25-6393 |
| Device Expiration Date | 2019-04-05 |
| 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 | 2018-08-30 |