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 2017-12-04 for BENZ BENZODIAZEPINES PLUS 04490789190 manufactured by Roche Diagnostics.
[94747384]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[94747385]
The customer requested information related to the relationship between benz benzodiazepines plus (benz) run on a cobas 6000 c (501) module and the drug clonazepam. The customer is a toxicologist who is gathering information for a criminal case he will be testifying in. The customer wanted sensitivity and specificity information related to clonazepam and the benz test. The customer was interested in the cross-reactivity between clonazepam and the metabolite against which benz is measured which is nordiazepam. The customer stated 1 patient urine sample was tested for benz and the result was "positive. " the actual result was not provided. The sample was repeated by gas chromatography? Mass spectrometry (gc/ ms) method and the result was "negative. " the actual result was not provided. The positive result was reported outside of the laboratory. No adverse event occurred due to the result from the device. The c501 module serial number was not provided. The customer was provided with cross-reactivity information from product labeling. Per product labeling the benz assay "provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gc/ms is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used. " the cross-reactivity for clonazepam is 68%. The cutoff for benz is 100 ng/ml. It would take 148 ng/ml of clonazepam to cause reactivity comparable to 100 mg/dl of the target drug nordiazepam. At the 100 ng/ml cutoff, it would take 148 ng/ml of clonazepam (more than the target drug of nordiazepam at cutoff) to cause a positive result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02819 |
| MDR Report Key | 7078956 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-04 |
| Date of Report | 2017-12-27 |
| Date of Event | 2017-09-15 |
| Date Mfgr Received | 2017-11-16 |
| Date Added to Maude | 2017-12-04 |
| 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 | 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 | 2017-12-04 |
| Model Number | NA |
| Catalog Number | 04490789190 |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-04 |