MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-02-05 for VITROS CHEMISTRY PRODUCTS BENZ REAGENT 6801989 manufactured by Ortho-clinical Diagnostics.
[15009104]
A customer observed false negative vitros benz result on one pt sample while using the vitros 5, 1 fs chemistry system. The magnitude and direction of the false negative vitros benz result observed may lead to inappropriate physician action. The original affected result was reported to the clinician, and a corrected report was later issued. There was no report of harm to the pt as a result of this event. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[15524830]
Investigation into this event concluded that a false negative benz result occurred. The most likely cause if a combination of a known limitation of the vitros benz reagent related to low cross reactivity with lorazepam glucuronide and use error in the interpretation of a vitros benz result. Confirmatory testing concludes that the vitros benz method identified a benzodiazepine compound at a much lower concentration than gc/ms. The intended use section of the vitros benz ifu states that the vitros chemistry product benz assay is intended for use by professional laboratory personnel. It provided only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with vitros benz assay. Gas chromatography/mass spectrometry (gc/ms) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result. No malfunction of the vitros benz reagent occurred. There was no allegation of pt harm as a result of this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2010-00002 |
| MDR Report Key | 1631970 |
| Report Source | 05 |
| Date Received | 2010-02-05 |
| Date of Report | 2010-01-08 |
| Date of Event | 2009-12-24 |
| Date Mfgr Received | 2010-01-08 |
| Device Manufacturer Date | 2009-06-01 |
| Date Added to Maude | 2010-10-15 |
| 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 | JOSEPH FALVO |
| Manufacturer Street | 100 INDIGO CREEK DRIVE |
| 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 | VITROS CHEMISTRY PRODUCTS BENZ REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JXM |
| Date Received | 2010-02-05 |
| Model Number | NA |
| Catalog Number | 6801989 |
| Lot Number | 1523-07-9075 |
| Device Expiration Date | 2010-08-01 |
| 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 DRIVE ROCHESTER NY 14626510 US 14626 5101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-02-05 |