MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-03 for BENZODIAZEPINES PLUS 04490789190 manufactured by Roche Diagnostics.
[12737028]
The investigation determined that lorazepam glucuronides react with the reagent at approximately 0. 5% cross-reactivity. The reagent does not contain glucuronidase. It was determined the assay was working according to specification and cross-reactivity claims.
Patient Sequence No: 1, Text Type: N, H10
[20779438]
The customer alleged instances where a patient was taking "lorazepine" and the doctor expected a positive result for the benzodiazepines plus assay, but the result was negative. Testing by mass spectrometer was positive for benzodiazepines. The customer stated she knew of "a couple of samples" that were expected to be positive due to patient medication, but were reported as negative. Following physician complaints the samples were tested by mass spectrometry and were positive for benzodiazepines with results as high as 12000 or 15000 (no units of measure were provided). The customer could not provide the actual dates on which these events occurred. No patients were adversely affected. The analyzer in use was a cobas 8000 c 502 module, serial number (b)(4). The field service representative could not find a cause and indicated the customer did not believe there to be a problem with the instrument. The field service representative ran a precision study which was acceptable.
Patient Sequence No: 1, Text Type: D, B5
[20948846]
It is unknown if the customer reported to fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-09566 |
| MDR Report Key | 4295848 |
| Report Source | 05,06 |
| Date Received | 2014-12-03 |
| Date of Report | 2014-12-15 |
| Date of Event | 2014-11-21 |
| Date Mfgr Received | 2014-11-21 |
| Date Added to Maude | 2014-12-03 |
| 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 | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENZODIAZEPINES PLUS |
| Generic Name | ENZYME IMMUNOASSAY, BENZODIAZIPINE |
| Product Code | JXM |
| Date Received | 2014-12-03 |
| Model Number | NA |
| Catalog Number | 04490789190 |
| Lot Number | 69386501 |
| ID Number | NA |
| Device Expiration Date | 2015-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-03 |