MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-02 for VITROS CHEMISTRY PRODUCTS VALP REAGENT 6801710 manufactured by Ortho-clinical Diagnostics.
[122662838]
The investigation concluded that higher and lower than expected results were obtained from three different levels of vitros tdm pv quality control fluids using vitros valp reagent, on a vitros 5,1 fs chemistry system. The assignable cause of the higher than expected vitros valp results obtained using vitros tdm pv fluids was determined to be calibration related. The responses and parameters of the affected calibration appeared atypical to expected responses and parameters. Recalibrating with an alternate set of calibrators from the same lot had resolved the issue. The definitive assignable cause of the lower than expected vitros tdm pv fluid results was unknown, however, pre-analytical sample mix up and improper fluid handling protocol could not be ruled out as contributing factors to the event. Within-run precision testing used to assess instrument performance was not performed and therefore an instrument issue cannot be ruled out as a potential contributor. Acceptable results were obtained from the same reagent packs that initially generated lower than expected results. Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros valp reagent lot 2511-25-6393. Therefore, a vitros valp reagent related issue did not likely contribute to the event.
Patient Sequence No: 1, Text Type: N, H10
[122662839]
A customer obtained higher and lower than expected results from three different levels of vitros tdm performance verifier (pv) quality control fluids using vitros valproic acid (valp) reagent on a vitros 5,1 fs chemistry system. Higher than expected results: vitros tdm pv i q5894 results of 277. 5 and 351. 7 umol/l vs. The expected result of 170 umol/l. Vitros tdm pv ii n5702 results of 602. 2 and 722. 5 umol/l vs. The expected result of 477. 5 umol/l. Vitros tdm pv iii p5703 results of 1039. 5 umol/l vs. The expected result of 835 umol/l. Lower than expected results: vitros tdm pv i q5894 results of <69. 3 (x5) umol/l vs. The expected result of 170 umol/l. Vitros tdm pv ii n5702 results of <69. 3 (x5) and 378. 3 umol/l vs. The expected result of 477. 5 umol/l. Vitros tdm pv iii p5703 results of <69. 3, <69. 3, 81. 9, 81. 9, and 137. 6 umol/l vs. The expected result of 835 umol/l. Biased results of the direction and magnitude observed may lead to inappropriate physician action if the issue were to occur undetected on patient samples. The unexpected vitros 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 actual patient harm as a result of this event. This report is number one of three mdr? S for this event. Three 3500a forms are being submitted for this event as three devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00027 |
| MDR Report Key | 7927548 |
| Date Received | 2018-10-02 |
| Date of Report | 2018-10-02 |
| Date of Event | 2018-09-05 |
| Date Mfgr Received | 2018-09-05 |
| Device Manufacturer Date | 2017-12-19 |
| Date Added to Maude | 2018-10-02 |
| 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 | 2018-10-02 |
| Catalog Number | 6801710 |
| Lot Number | 2511-25-6393 |
| Device Expiration Date | 2019-04-05 |
| 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 | 2018-10-02 |