MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-05-28 for VIRTROS CHEMISTRY PRODUCTS BENZ REAGENT PACK 6801989 manufactured by Ortho-clinical Diagnostics.
[1220563]
The customer obtained a false negative patient result during a patient correlation test using vitros benz reagent on the vitros 5,1 fs chemistry system. Confirmatory testing with gc/ms indicated the presence of oxazepam, a benzodiazepine compound. Biased results of the direction and magnitude observed may lead to inappropriate physician action. The false negative result was not reported as the sample was processed for correlation testing only. There was no report of patient harm as a result of this event. This report corresponds to ortho-clinical diagnostics inc. (b)(4)
Patient Sequence No: 1, Text Type: D, B5
[8402912]
Investigation into this event found that the vitros 5,1 and vitros benz reagent performed as intended. Confirmatory testing with gas chromatography/mass spectrometry (gc/ms) indicated that the patient sample contained oxazepam. Both the vitros benz method and the competitive method used in the correlation testing identified a benzodiazepine compound at a much lower concentration than gc/ms. This data indicates that both methods under recovered the quantity of benzodiazepines in the patient sample. The vitros benz ifu indicates that reference methods hydrolyze benzodiazine glucuronides in the extraction process, increasing the recovery of benzodiazepines by the reference method as compared to the vitros benz assay. The most likely root cause for the false negative vitros benz result is that the patient sample contained oxazepam glucuronide which is almost undetectable by the vitros benz reagent.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2008-00158 |
| MDR Report Key | 1509296 |
| Report Source | 05 |
| Date Received | 2009-05-28 |
| Date of Report | 2009-04-29 |
| Date of Event | 2009-03-25 |
| Date Mfgr Received | 2009-04-29 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2010-08-11 |
| 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 | JOE FALVO |
| Manufacturer Street | 100 INDIGO CREEK DR |
| Manufacturer City | ROCHESTER NY 146265101 |
| Manufacturer Country | US |
| Manufacturer Postal | 146265101 |
| Manufacturer Phone | 5854535735 |
| 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 | VIRTROS CHEMISTRY PRODUCTS BENZ REAGENT PACK |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JXM |
| Date Received | 2009-05-28 |
| Model Number | NA |
| Catalog Number | 6801989 |
| Lot Number | 1523-05-8672 |
| ID Number | NA |
| Device Expiration Date | 2009-08-01 |
| 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 DR ROCHESTER NY 14626510 US 14626 5101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-05-28 |