MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-10-11 for BENZODIAZEPINES 20737984122 manufactured by Roche Diagnostics.
[3879980]
The customer stated they have an ongoing issue with questionable benzodiazepine results for one or two urine samples per day. Data was only provided for one patient sample where the result was positive but then confirmed negative by gc-ms. The initial result was >2000 ng/ml with a data flag. On (b)(6) 2013, the result by gc-ms was negative. The initial result was reported outside the lab. There were no adverse events reported. The benzodiazepine reagent lot number was 680717 with an expiration date of 08/31/2014.
Patient Sequence No: 1, Text Type: D, B5
[11138326]
The investigation could not determine a specific root cause as the sample was not available for further testing. The sample showed a high titer of cotinine. Cotinine is an indicator for smoker especially a high cotinine and thiocyanate concentration in the sample. Smokers are building so-called ss-carbolines, like harmane and norharmane, which are structural very similar to benzodiazepines and can bind to the benzodiazepine receptors as endogenous inhibitors. Due to the structural similarity these substances could also bind to the anti- benzodiazepine antibody in the assay.
Patient Sequence No: 1, Text Type: N, H10
[11283417]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-06252 |
| MDR Report Key | 3406079 |
| Report Source | 05,06 |
| Date Received | 2013-10-11 |
| Date of Report | 2013-10-17 |
| Date of Event | 2013-09-13 |
| Date Mfgr Received | 2013-09-17 |
| Date Added to Maude | 2013-10-11 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| 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 |
| Generic Name | ENZYME IMMUNOASSAY, BENZODIAZIPINE |
| Product Code | NFV |
| Date Received | 2013-10-11 |
| Model Number | NA |
| Catalog Number | 20737984122 |
| Lot Number | NA |
| ID Number | NA |
| 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 | 2013-10-11 |