MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-06 for VITROS CHEMISTRY PRODUCTS VALP REAGENT 6801710 manufactured by Ortho-clinical Diagnostics.
[102079594]
The investigation determined that lower than expected valproic acid results were obtained from non-vitros biorad (lot 40900) quality control fluids processed using vitros valp reagent with a vitros 5600 integrated system. A definitive assignable cause cannot be determined. An unknown transient issue with the vitros valp reagent lot 1511-25-5974 on the day of the event could not be ruled out as a contributing factor to the event. The valp reagent storage and handling protocols were reviewed and no issues were identified. An instrument issue is not a likely contributing factor as other vitros microtip assays were performing as expected and a vitros 5600 instrument malfunction was not reported.
Patient Sequence No: 1, Text Type: N, H10
[102079595]
A customer obtained lower than expected vitros valproic acid (valp) results from non-vitros biorad (lot 40900) quality control fluids using vitros valp reagent in combination with a vitros 5600 integrated system. (b)(6). Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The lower than expected valp 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. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00012 |
| MDR Report Key | 7315927 |
| Date Received | 2018-03-06 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-02-06 |
| Date Mfgr Received | 2018-02-07 |
| Device Manufacturer Date | 2017-02-14 |
| Date Added to Maude | 2018-03-06 |
| 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 | 2018-03-06 |
| Catalog Number | 6801710 |
| Lot Number | 1511-25-5974 |
| ID Number | 10758750006748 |
| Device Expiration Date | 2018-08-14 |
| 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 | 2018-03-06 |