MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-01 for VITROS 5,1FS CHEMISTRY SYSTEM 6801890 manufactured by Ortho-clinical Diagnostics.
[92069736]
The investigation determined that higher than expected vitros valp quality control results were obtained from vitros and non-vitros qc fluids run on a vitros 5,1fs chemistry system. A definitive assignable cause could not be determined. However, the most likely assignable cause is instrument related. Maintenance actions following monthly maintenance described in the ortho operator? S guide likely resolved the issue. There is no indication a reagent issue contributed to the event. The investigation determined that the likely assignable cause of this event was instrument related.
Patient Sequence No: 1, Text Type: N, H10
[92069737]
A customer observed higher and lower than expected vitros valp quality control results from vitros and non-vitros biorad control fluids processed on the vitros 5,1 fs chemistry system. Vitros tdm i lot m5701 vitros results 19. 0 and 18. 52 ug/ml versus expected 29. 2 ug/ml. Vitros tdm ii lot n5702 vitros results 53. 45 and 51. 46 ug/ml versus expected 68. 9 ug/ml. Non-vitros biorad l3 lot 40943 vitros result 39. 68 ug/ml versus expected 29. 0 ug/ml. Biased results of the direction and magnitude observed could lead to inappropriate physician action. Ortho was not made aware of any patient sample results being affected. 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 was no allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint numbers (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319681-2017-00100 |
| MDR Report Key | 6993502 |
| Date Received | 2017-11-01 |
| Date of Report | 2017-11-01 |
| Date of Event | 2017-09-29 |
| Date Mfgr Received | 2017-10-04 |
| Device Manufacturer Date | 2005-07-22 |
| Date Added to Maude | 2017-11-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | 100 INDIGO CREEK DRIVE |
| Manufacturer City | ROCHESTER NY 14626 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14626 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VITROS 5,1FS CHEMISTRY SYSTEM |
| Generic Name | CHEMISTRY ANALYZER |
| Product Code | LEG |
| Date Received | 2017-11-01 |
| Catalog Number | 6801890 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| 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 | 2017-11-01 |