MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-02-24 for ONLINE DAT BENZODIAZEPINES PLUS 04490789190 manufactured by Roche Diagnostics.
[5515882]
The customer reported that they received an erroneous result for one patient urine sample tested for benzodiazepines plus (benz). The sample initially resulted as negative on a c501 analyzer and this result was reported outside of the laboratory. The doctor indicated that the sample should have been positive and asked for a re-test. The sample was sent to a different laboratory for repeat testing. The sample was repeated using gc/ms methodology and resulted as 1100 ng/ml for lorazepam, which is considered positive. The repeat result was believed to be correct. The patient was not adversely affected. The c501 analyzer serial number was (b)(4). A qualitative 200 ng/ml cutoff was used for the benz assay. The benz assay is specifically standardized for nordiazepam and will detect other benzodiazepine metabolites at varying degrees of reactivity. The field application specialist explained to the customer that there is a 59 percent cross reactivity of the assay to lorazepam at the 200 ng/ml cutoff. It was suggested to the customer to lower the cutoff of the assay in order to increase sensitivity.
Patient Sequence No: 1, Text Type: D, B5
[12843943]
It was unknown if the initial reporter sent a report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[16613331]
Investigations have determined that with a cut off of 200 ng/ml, the test result should be positive if only lorazepam is present in urine. Usually, urine contains a mix or an even higher concentration of the metabolite lorazepam glucuronide. The benz assay does not contain glucoronidase and the instructions for use state the cross-reactivity to lorazepam glucuronide as 0. 5 %. Thus, the result can be negative when a higher glucuronide concentration is present in the urine. Gc-ms methods usually treat the sample with glucoronidase, thus both substances lorazepam and lorazepam glucuronide are detected and measured. A treatment with glucoronidase has to be considered. The assay was found to be working within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-01493 |
| MDR Report Key | 4541834 |
| Report Source | 05,06 |
| Date Received | 2015-02-24 |
| Date of Report | 2015-03-17 |
| Date of Event | 2015-01-26 |
| Date Mfgr Received | 2015-02-09 |
| Date Added to Maude | 2015-02-24 |
| 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 | ONLINE DAT BENZODIAZEPINES PLUS |
| Generic Name | ENZYME IMMUNOASSAY, BENZODIAZIPINE |
| Product Code | JXM |
| Date Received | 2015-02-24 |
| Model Number | NA |
| Catalog Number | 04490789190 |
| Lot Number | 60044301 |
| ID Number | NA |
| Device Expiration Date | 2015-10-31 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-24 |