MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-05-22 for VITROS CHEMISTRY PRODUCTS BENZ REAGENT 6801989 manufactured by Ortho-clinical Diagnostics.
[3567699]
This customer observed a discordant, negative vitros benz result (<85 (negative) vs. An expected result = 1015 ng/ml (positive)) from a single patient sample using the vitros 5,1 fs chemistry system. The affected result was reported out of the laboratory. Biased patient results of the direction and magnitude observed could lead to inappropriate physician action. The physician questioned the result as a positive test result was expected. The sample was sent for confirmatory testing using a gc/ms method. A corrected report was issued. There was no report of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10842821]
The investigation determined that a negative vitros benz result was obtained from a single patient sample using the vitros 5,1 fs chemistry system. 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. The most likely cause is a known limitation of the vitros benz reagent related to low cross reactivity with lorazepam. There is no evidence that a reagent related issue contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319808-2013-00031 |
| MDR Report Key | 3124956 |
| Report Source | 05 |
| Date Received | 2013-05-22 |
| Date of Report | 2013-05-22 |
| Date of Event | 2013-04-18 |
| Date Mfgr Received | 2013-04-23 |
| Device Manufacturer Date | 2012-10-26 |
| Date Added to Maude | 2013-07-31 |
| 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 | 2013-05-22 |
| Catalog Number | 6801989 |
| Lot Number | 1523-15-2524 |
| Device Expiration Date | 2013-10-01 |
| 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 | 2013-05-22 |