MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-25 for VITROS CHEMISTRY PRODUCTS VALP REAGENT 6801710 manufactured by Ortho-clinical Diagnostics.
[136147966]
The investigation determined that higher than expected results were obtained from two different levels of non-vitros biorad unassayed multiqual controls, lot 47940, using vitros valp reagent on a vitros 5600 integrated system. The assignable cause of the higher than expected results is unknown, however, a calibration related event or improper sample handling protocol cannot be completely ruled out as contributing to the event. Acceptable vitros valp performance was obtained after an additional calibration event, which would indicate the vitros valp reagent did not contribute to the event. A vitros valp within-run precision test was performed and the results were within in the acceptable criteria, indicating vitros valp reagent lot 2511-26-6711 was currently performing as intended on the vitros 5600 system. However, the precision test was performed approximately one month after the initial event occurred, so the performance of the vitros 5600 system at the time of the event cannot be verified. Therefore, an instrument related issue cannot be completely ruled out as contributing to the event.
Patient Sequence No: 1, Text Type: N, H10
[136147967]
A customer obtained higher than expected results from two different levels of non-vitros biorad unassayed multiqual controls, lot 47940, using vitros valp (valproic acid) reagent on a vitros 5600 integrated system. Biorad l2 results of 74. 5, 72. 3, 72. 3, and 72. 2 ug/ml vs. The expected result of 60. 0 ug/ml. Biorad l3 results of 135. 3 and 126. 7 ug/ml vs. The expected result of 105. 0 ug/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. Patient samples were not run for vitros valp over the time frame of the event; as the vitros valp quality control results were outside of the established control range. 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 actual patient harm. This report is number three of three mdr? S for this event. Three 3500a forms are being submitted for this event as a total of three devices were involved. This report corresponds to ortho clinical diagnostics inc (ortho). Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2019-00004 |
| MDR Report Key | 8277684 |
| Date Received | 2019-01-25 |
| Date of Report | 2019-01-25 |
| Date of Event | 2018-12-04 |
| Date Mfgr Received | 2018-12-31 |
| Device Manufacturer Date | 2018-06-19 |
| Date Added to Maude | 2019-01-25 |
| 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 DIAGNOSTIC |
| Product Code | LEG |
| Date Received | 2019-01-25 |
| Catalog Number | 6801710 |
| Lot Number | 2511-26-6711 |
| Device Expiration Date | 2019-08-08 |
| 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 | 2019-01-25 |