MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-11 for VITROS CHEMISTRY PRODUCTS VALP REAGENT 6801710 manufactured by Ortho-clinical Diagnostics.
[139328053]
The investigation determined that higher and lower than expected vitros valproic acid (valp) results were obtained from non-vitros quality control (qc) fluids processed using vitros chemistry products valp reagent in combination with a vitros 5600 integrated system. A definitive assignable cause for the events could not be determined. Historical vitros valp quality control results confirm the observed imprecision, however the cause of the imprecision is unknown. The customer is calibrating frequently which may be contributing to the imprecision. The within run valp precision test results were not performed as requested, therefore a vitros 5600 integrated system issue could not be entirely ruled out. The vitros valp quality control results were acceptable after a recalibration event on (b)(6) 2019, therefore vitros valp lot 2511-26-6892 is not likely to be a contributor to the event. In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros valp reagent lot 2511-26-6892. No information was obtained regarding sample handling, it is possible the customer is not handling the control fluids consistently day to day which could contribute to imprecise results.
Patient Sequence No: 1, Text Type: N, H10
[139328054]
A customer initially reported higher than expected vitros valproic acid (valp) quality results obtained from non-vitros quality control (qc) fluids using vitros chemistry products valp reagent on a vitros 5600 integrated system. An investigation later discovered lower than expected vitros valp results obtained from non-vitros quality control (qc) fluids using vitros chemistry products valp reagent on a vitros 5600 integrated system. Biorad immunoassay plus control lot 40951 vitros valp results 19. 5, 51. 4 and 52. 7 ug/ml versus the expected vitros valp result 40. 4 ug/ml. Biorad immunoassay plus control lot 40952 vitros valp results 52. 6, 91. 8 and 92. 5 ug/ml versus the expected vitros valp result 75. 8 ug/ml. Biorad immunoassay plus control lot 40953 vitros valp results 69. 9, 70. 8, 72. 0 and 78. 9 ug/ml versus the expected vitros valp result 109. 0 ug/ml. 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 and lower than expected vitros valp results were obtained when processing quality control fluids. However, the investigation cannot definitively conclude that patient sample results were not affected or would not be affected if the event were to recur undetected. There have been no allegations of patient harm as a result of this event. This report is number 1 of 2 mdr? S for this event. Two (2) 3500a forms are being submitted for this event as 2 devices were involved. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2019-00010 |
| MDR Report Key | 8410015 |
| Date Received | 2019-03-11 |
| Date of Report | 2019-03-11 |
| Date of Event | 2019-02-06 |
| Date Mfgr Received | 2019-02-14 |
| Device Manufacturer Date | 2018-05-31 |
| Date Added to Maude | 2019-03-11 |
| 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 | 2019-03-11 |
| Catalog Number | 6801710 |
| Lot Number | 2511-26-6892 |
| 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 | 2019-03-11 |