MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-11-16 for VITROS CHEMISTRY PRODUCTS OP REAGENT 6801997 manufactured by Ortho-clinical Diagnostics.
[17555757]
The customer obtained a non-reproducible, negative vitros op result for a known positive quality control fluid processed on the vitros 5,1 fs chemistry system. Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected with a patient sample. No patient results were known to have been affected. There was no report of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[17817275]
The investigation determined that a non-reproducible, false negative vitros op result was obtained for a known positive quality control fluid. Patient samples were not known to have been affected. The customer recalibrated their in-use vitros op reagent lot, and acceptable performance was obtained following recalibration. A definitive root cause for the event could not be determined. However, a control fluid issue and/or an equipment or reagent related issue cannot be ruled out as contributing factors.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2011-00039 |
| MDR Report Key | 2339413 |
| Report Source | 05 |
| Date Received | 2011-11-16 |
| Date of Report | 2011-11-16 |
| Date of Event | 2011-10-28 |
| Date Mfgr Received | 2011-10-28 |
| Device Manufacturer Date | 2011-06-07 |
| Date Added to Maude | 2012-07-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. JOSEPH FALVO |
| 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 | 3 |
| Brand Name | VITROS CHEMISTRY PRODUCTS OP REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | DJG |
| Date Received | 2011-11-16 |
| Catalog Number | 6801997 |
| Lot Number | 1527-06-1506 |
| Device Expiration Date | 2012-09-01 |
| 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 | 2011-11-16 |