MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-14 for VITROS CHEMISTRY PRODUCTS VALP REAGENT 6801710 manufactured by Ortho-clinical Diagnostics.
[100430313]
The investigation determined that lower and higher than expected vitros valp quality control results were obtained from non-vitros qc fluids run on a vitros 5600 integrated system. A definitive assignable cause for the lower than expected results was not determined. However the higher than expected result was most likely due to a suboptimal calibration. Historical quality control results indicate the valp reagent is not a likely contributing factor to the event, as the qc was acceptable up to the day of the event. However, a transient issue with the instrument or the reagent pack in use at the time of each event could not be ruled out as a potential contributors to the events. There is no indication of an instrument issue as acceptable within-run precision results were obtained indicating the vitros 5600 system was performing as expected.
Patient Sequence No: 1, Text Type: N, H10
[100430314]
A customer observed higher and lower than expected vitros valp quality control results from non-vitros biorad control fluids processed on the vitros 5600 integrated system. Biorad l1 lot 31820 vitros results 20. 53 and 21. 77 ug/ml versus expected 34 ug/ml. Biorad l2 lot 31820 vitros result of 189. 96 ug/ml versus expected 140 ug/ml. Biased results of the direction and magnitude observed could lead to inappropriate physician action. The customer confirmed that no erroneous patient sample results were obtained or reported. However, the investigation cannot definitively conclude that patient sample results would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of this event. This report is number two of two 3500a forms filed for this event, as two devices were affected. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2018-00011 |
| MDR Report Key | 7269435 |
| Date Received | 2018-02-14 |
| Date of Report | 2019-01-04 |
| Date of Event | 2017-12-28 |
| Date Mfgr Received | 2018-01-16 |
| Device Manufacturer Date | 2017-02-14 |
| Date Added to Maude | 2018-02-14 |
| 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 | 2018-02-14 |
| Catalog Number | 6801710 |
| Lot Number | 2511-25-5974 |
| ID Number | 10758750006748 |
| Device Expiration Date | 2018-08-14 |
| 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 | 2018-02-14 |