MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-15 for VITROS CHEMISTRY PRODUCTS VALP REAGENT 6801710 manufactured by Ortho-clinical Diagnostics.
[108806884]
The investigation determined that a higher than expected valproic acid result was obtained from a non-vitros biorad quality control fluid processed using vitros valp reagent with a vitros 5600 integrated system. A definitive assignable cause could not be determined. A review of historical non-vitros quality control results confirmed acceptable performance of vitros valp reagent lot. In addition, a diagnostic within run precision test verified the vitros 5600 system performance. An ortho field engineer went on site and processed vitros tdm performance verifiers and biorad quality control fluids to access the performance of the system prior to any potential service actions. All vitros valp results obtained when processing the controls were acceptable indicating that vitros valp lot in combination with the vitros 5600 system was performing as expected and no service actions were warranted. There is no evidence to suggest the vitros 5600 system or vitros valp reagent lot contributed to the event. It is unknown if the customer properly handled the quality control fluid prior to processing on the vitros 5600 system. Improper fluid handling could not be ruled out as a potential contributing factor to the event.
Patient Sequence No: 1, Text Type: N, H10
[108806885]
A customer obtained a higher than expected valproic acid (valp) result from a non-vitros biorad quality control fluid (biorad lot 40941 = 102. 4 vs. Expected 69. 3 ug/ml) using vitros valp reagent in combination with a vitros 5600 integrated system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples. The higher than expected valp result was generated from a non-patient fluid, 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 the event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00014 |
| MDR Report Key | 7514827 |
| Date Received | 2018-05-15 |
| Date of Report | 2018-05-15 |
| Date of Event | 2018-04-15 |
| Date Mfgr Received | 2018-04-17 |
| Device Manufacturer Date | 2017-02-14 |
| Date Added to Maude | 2018-05-15 |
| 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 | 2018-05-15 |
| Catalog Number | 6801710 |
| Lot Number | 2511-25-5974 |
| ID Number | 10758750006748 |
| Device Expiration Date | 2018-08-14 |
| 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 | 2018-05-15 |