MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-08 for VITROS CHEMISTRY PRODUCTS VALP REAGENT 6801710 manufactured by Ortho-clinical Diagnostics.
[111046853]
The investigation determined that lower than expected vitros valp results were obtained during a patient correlation when using vitros valp reagent on a vitros 5600 integrated system. The investigation was unable to determine an assignable cause for the lower than expected vitros valp results. Diagnostic within run vitros gent and vitros dldl precision tests were within ortho guidelines indicating the vitros 5600 system was performing as expected. Therefore, an instrument related issue is not likely a contributor of the event. There were no historical quality control results to confirm the performance of vitros valp reagent lot 2511-25-6393 prior to the event. The customer did not place this lot into routine use due to biased low results from non-vitros biorad level 3 control fluid when compared to the biorad peer group mean. However, the customer did process vitros tdm performance verifier fluids during the investigation and results were within the vitros control assay sheet range of means, indicating acceptable accuracy. Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros valp reagent lot 2511-25-6393. The lower than expected vitros valp results were obtained during a patient sample correlation. The pre-analytical handling of samples used for the patient correlation was unknown. Additional patient correlations were performed which generated acceptable valp results. Although sample handling and/or the stability of the samples is the likely cause of the lower than expected vitros valp results, without additional information regarding the correlation procedure this could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[111046854]
The customer obtained lower than expected vitros valp results were obtained during a patient correlation when using vitros valp reagent on a vitros 5600 integrated system. Patient sample 6 vitros valp = 41. 9 ug/ml versus expected vitros valp 55 ug/ml. Patient sample 9 vitros valp = 31. 5 ug/ml versus expected vitros valp 50 ug/ml. Patient sample 12 vitros valp = 65. 6 ug/ml versus expected vitros valp 82 ug/ml. Patient sample 15 vitros valp = 37. 3 ug/ml versus expected vitros valp 51 ug/ml. Patient sample 19 vitros valp = 46. 5 ug/ml versus expected vitros valp 61 ug/ml. Patient sample 20 vitros valp = 74. 9 ug/ml versus expected vitros valp 95 ug/ml. Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected. The lower than expected valp results were obtained during a patient correlation and the results were not reported outside of the laboratory. The customer was not performing routine valp patient testing at the time of the event. 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 | 1319808-2018-00017 |
| MDR Report Key | 7583981 |
| Date Received | 2018-06-08 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-05-13 |
| Date Mfgr Received | 2018-05-13 |
| Device Manufacturer Date | 2017-10-05 |
| Date Added to Maude | 2018-06-08 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | 2018-06-08 |
| Catalog Number | 6801710 |
| Lot Number | 2511-25-6393 |
| ID Number | 10758750006748 |
| Device Expiration Date | 2019-04-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2018-06-08 |