MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-04 for VITROS CHEMISTRY PRODUCTS VALP REAGENT 6801710 manufactured by Ortho-clinical Diagnostics.
[125130748]
The investigation confirmed lower and higher than expected results were obtained from two different levels of vitros tdm performance verifier (pv) quality control fluids using vitros valproic acid (valp) reagent when tested on two different vitros 4600 chemistry systems. The assignable cause of the lower and higher than expected vitros valp results obtained on the vitros 4600 system ((b)(4)) was an instrument related issue. Vitros valp within-run precision testing was outside of acceptable guidelines, and within-lab imprecision was observed using two valp reagent lots, where acceptable precision was obtained on one of the valp reagent lots tested on an alternate vitros 4600 system. In addition, historical vitros valp quality control results were not acceptable, as vitros valp results shifted low each time a new reagent pack was loaded. Therefore, an unknown reagent pack issue, or improper reagent pack handling or storage cannot be ruled out as contributing to the event. Ortho field service will be sent to the site to investigate the performance of (b)(4). The definitive assignable cause of the lower and higher than expected vitros valp results obtained on the vitros 4600 system ((b)(4)) is unknown. A review of historical vitros valp quality control results demonstrated within-lab imprecision. It was noted that the vitros valp results shifted low each time a new reagent pack was loaded. Therefore, an unknown reagent pack issue, or improper reagent pack handling or storage cannot be ruled out as contributing to the event. Vitros within-run precision testing was within acceptable guidelines, indicating the vitros 4600 system was performing as intended and did not likely contribute to the event.
Patient Sequence No: 1, Text Type: N, H10
[125130769]
A customer obtained lower and higher than expected results from two different levels of vitros tdm performance verifier (pv) quality control fluids using vitros valproic acid (valp) reagent on two different vitros 4600 chemistry systems. Vitros 4600 chemistry system, (b)(4): vitros tdm y6278 results of 14. 5, 13. 8, <10. 0, <10. 0, 39. 7, 39. 5, 42. 0, <10. 0, <10. 0, <10. 0, <10. 0, 13. 7, and 13. 5 ug/ml vs. The expected result of 25. 5 ug/ml. Vitros tdm b6280 results of 83. 5, 46. 0, 56. 1, 135. 7, 37. 2, 35. 3, 48. 4, 51. 2, 83. 3, 81. 9, 75. 7, and 78. 0 ug/ml vs. The expected result of 112. 0 ug/ml. Vitros 4600 chemistry system, (b)(4): vitros tdm y6278 results of 11. 3, 11. 0, 11. 2, 39. 6, 42. 4, 42. 1, 11. 2, 11. 2, 12. 7, 40. 0, 41. 0, 40. 4, 41. 7, 35. 3, 35. 2, 34. 8, 35. 0, 35. 1, 35. 8, 34. 8, 11. 5, and 12. 2 ug/ml vs. The expected result of 24. 65 ug/ml. Vitros tdm b6280 results of 72. 6, 71. 9, 74. 0, 75. 9, 132. 8, 136. 7, 85. 6, 87. 0, 74. 4, 73. 6, 77. 6 and 137. 5 ug/ml vs. The expected result of 112. 29 ug/ml. Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected. The unexpected vitros valp results were generated from non-patient fluids, however the investigation cannot conclude that patient sample results would be affected if the event were to recur undetected. However, there was no report of affected patient results and there was no allegation of actual patient harm as a result of this event. This report is number two of ten mdr? S for this event. Ten 3500a forms are being submitted for this event as a total of ten devices were involved. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00030 |
| MDR Report Key | 7935469 |
| Date Received | 2018-10-04 |
| Date of Report | 2018-10-04 |
| Date of Event | 2018-06-12 |
| Date Mfgr Received | 2018-09-06 |
| Device Manufacturer Date | 2017-12-19 |
| Date Added to Maude | 2018-10-04 |
| 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 | 2018-10-04 |
| 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 | 2018-10-04 |