MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-08-17 for BENZ BENZODIAZEPINES PLUS 04490789190 manufactured by Roche Diagnostics.
[117446516]
Na.
Patient Sequence No: 1, Text Type: N, H10
[117446517]
The customer complained of false negative benz benzodiazepines plus results for 4 patient urine samples on a cobas 6000 c (501) module serial number (b)(4). Of the data provided, there was a discrepant benz result for 1 patient urine sample. The benzodiazepines result was negative on the c 501 module. The physician questioned the result and requested confirmation testing as the patient was taking clonazepam. The aminoclonazepam result was 156 ng/ml with the medmatch mass spectrophotometry using the same sample. According to product labeling, a 7-aminoclonazepam result of 144 ng/ml or greater should yield a positive result. There was no allegation of an adverse event. The product labeling states "many benzodiazepines appear in the urine largely as the glucuronidated conjugate. Glucuronidated metabolites may have more or less cross-reactivity than the parent compound. " the customer declined a service visit. The investigation was unable to find a definitive root cause.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02746 |
| MDR Report Key | 7792458 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-17 |
| Date of Report | 2018-08-17 |
| Date of Event | 2018-07-26 |
| Date Mfgr Received | 2018-07-26 |
| Date Added to Maude | 2018-08-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 | BENZ BENZODIAZEPINES PLUS |
| Generic Name | ENZYME IMMUNOASSAY, BENZODIAZEPINE |
| Product Code | JXM |
| Date Received | 2018-08-17 |
| Model Number | NA |
| Catalog Number | 04490789190 |
| Lot Number | 279762 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-17 |