MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-05-21 for VITROS CHEMISTRY PRODUCTS BENZ REAGENT 6801989 manufactured by Ortho-clinical Diagnostics.
[1544246]
A false negative vitros benz result was obtained from a proficiency 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 if it occurred on a patient sample. Patient samples were not affected and there was no allegation of patient harm. This report corresponds to ortho clinical diagnostics inc. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[8656828]
Investigation into this event concluded that a false negative benz result occurred. The most likely cause is a combination of a known limitation of the vitros benz reagent related to low cross reactivity with lorazepam and use error in the interpretation of a vitros benz result. The proficiency sample contained lorazepam and at target concentration of 1000 ng/ml and the vitros benz reagent identified a benzodiazepine compound at a much lower concentration of 260 ng/ml. 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 provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with the vitros benz assay. Gas chromatography/mass spectrometry (gc/ms) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result. No malfunction of the vitros benz reagent occurred. There was no allegation of patient harm as a result of this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2010-00011 |
| MDR Report Key | 1695522 |
| Report Source | 05 |
| Date Received | 2010-05-21 |
| Date of Report | 2010-05-21 |
| Date of Event | 2010-03-12 |
| Date Mfgr Received | 2010-04-23 |
| Device Manufacturer Date | 2009-10-31 |
| Date Added to Maude | 2011-12-23 |
| 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 BENZ REAGENT |
| Generic Name | IN-VITRO DIAGNOSTIC |
| Product Code | JXM |
| Date Received | 2010-05-21 |
| Catalog Number | 6801989 |
| Lot Number | 1523-09-9381 |
| Device Expiration Date | 2010-12-01 |
| 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 14626 US 14626 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-05-21 |