MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-28 for VITROS CHEMISTRY PRODUCTS BENZ REAGENT 6801989 manufactured by Ortho-clinical Diagnostics.
[56348739]
The investigation determined that a discordant, negative vitros benz result was obtained from a single patient sample using the vitros 5600 integrated system, when compared to a positive result obtained using two different non-vitros methods. The compound detected by the non-vitros methods was temazepam glucuronide. 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 temazepam glucuronide. There is no evidence that a reagent related issue contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[56348740]
A customer obtained a discordant, negative vitros benz result for single patient sample run on the vitros 5600 integrated system when compared to a positive result obtained using two different non-vitros methods. Patient result of <85 ng/ml vs. An expected result of 2977 ng/ml. Biased patient results of the direction and magnitude observed could lead to inappropriate physician action. The discordant, negative result was not reported out of the laboratory and there was no report of patient harm as a result of this event. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319808-2016-00017 |
| MDR Report Key | 5983247 |
| Date Received | 2016-09-28 |
| Date of Report | 2016-09-28 |
| Date of Event | 2016-08-09 |
| Date Mfgr Received | 2016-09-08 |
| Device Manufacturer Date | 2015-12-30 |
| Date Added to Maude | 2016-09-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JAMES A STEVENS |
| 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 | 0 |
| Brand Name | VITROS CHEMISTRY PRODUCTS BENZ REAGENT |
| Generic Name | IN VITRO DIAGNOSTIC |
| Product Code | JXM |
| Date Received | 2016-09-28 |
| Catalog Number | 6801989 |
| Lot Number | 1523-28-5023 |
| Device Expiration Date | 2017-03-30 |
| 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 | 2016-09-28 |