MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-09 for VITROS CHEMISTRY PRODUCTS VALP REAGENT 6801710 manufactured by Ortho-clinical Diagnostics.
[90312235]
The investigation has determined that lower and higher than expected vitros valp results were obtained from testing vitros tdm performance verifier qc material samples processed using vitros chemistry products valp reagent, lot 2511-25-5727 on vitros 5600 integrated system s/n (b)(4). The most likely assignable cause of the event is pre-analytical sample handling. The proper pre-analytical fluid handling protocol was communicated to the customer (to allow the fluid material to equilibrate to room temperature prior to testing), and once the protocol errors were addressed, the issue was resolved. A vitros valp reagent and a vitros 5600 instrument malfunction are not likely contributing factors.
Patient Sequence No: 1, Text Type: N, H10
[90312236]
A customer contacted ortho technical solutions center (tsc) to report lower and higher than expected vitros valp results obtained from testing vitros tdm performance verifiers on a vitros 5600 system. Vitros tdm pvi (lot b5000) vitros valp results 36. 71, 11. 36, and 11. 00 ug/ml versus the expected vitros valp result 26. 67 ug/ml. Vitros tdm pvii (lot k5350) vitros valp results 82. 46, 82. 61, 84. 88, 83. 56, 40. 28, and 40. 49 ug/ml versus the expected vitros valp result 68. 05 ug/ml. Vitros tdm pviii (lot d5002) vitros valp results 73. 36 and 73. 80 ug/ml versus the expected vitros valp result 113. 14 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 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. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2017-00021 |
| MDR Report Key | 6928092 |
| Date Received | 2017-10-09 |
| Date of Report | 2017-10-09 |
| Date of Event | 2017-09-03 |
| Date Mfgr Received | 2017-09-12 |
| Device Manufacturer Date | 2016-10-31 |
| Date Added to Maude | 2017-10-09 |
| 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 | 2017-10-09 |
| Catalog Number | 6801710 |
| Lot Number | 2511-25-5727 |
| ID Number | 10758750006748 |
| Device Expiration Date | 2018-04-30 |
| 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 | 2017-10-09 |