MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-01-14 for ONLINE DAT BENZODIAZEPINES PLUS 04499069190 manufactured by Roche Diagnostics.
[5279150]
The customer reported that they have received false positive results for two samples from the same patient tested for benzodiazepines plus (benz) on a p module analyzer. For the benz test, the customer uses a semi-quantitative application with a 200 ng/ml cutoff. The first sample initially resulted as 559 ng/ml and this value was reported outside of the laboratory as positive. The sample was sent to a confirmatory laboratory and repeated for confirmation using lc-ms/ms methodology. The lc-ms/ms confirmation results were negative for nordiazepam, oxazepam, temazepam, lorazepam, flurazepam metabolite, and alprazolam. The confirmation results were believed to be correct. The second sample was initially tested on (b)(6) 2014 and resulted as 485 ng/ml which was reported outside of the laboratory as positive. The confirmation results were believed to be correct. The sample was repeated by itself to verify if it still recovered positive and to rule out carry over from another sample or reagent. The repeat benz result was 351 ng/ml, which is considered positive. The sample was also retested at the confirmatory laboratory with an extended metabolite panel, resulting as negative for clonazepam. The patient was not adversely affected. The p module analyzer serial number was (b)(4). The customer declined a service visit. The patient is taking naltrexone medication and it was determined that naltrexone does not cross-react with the benz test. The customer has stated that they have multiple drugs of abuse test open channels on the analyzer in question. It was determined that there were no special washes in place for several of these tests, including: "etg", "xtc", "tca", "bups", "amp-c", "barbc", and "k2".
Patient Sequence No: 1, Text Type: D, B5
[12815685]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[12891220]
As part of investigations, it was noted that the expected maximum concentrations of naltrexone main metabolite and sitagliptine are both slightly below a level that can render them candidates for an interference. But both in sum and taken together could exceed the critical threshold under certain circumstances, though this does not seem likely.
Patient Sequence No: 1, Text Type: N, H10
[13105124]
For investigations, the combination naltrexone and sitagliptine was tested and a possible interference with the combination can be ruled out. The patient sample is not available for further investigation. It has been concluded that an unknown substance in the sample is interfering with the assay.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-00319 |
| MDR Report Key | 4419151 |
| Report Source | 05,06 |
| Date Received | 2015-01-14 |
| Date of Report | 2015-03-23 |
| Date of Event | 2014-12-17 |
| Date Mfgr Received | 2014-12-30 |
| Date Added to Maude | 2015-01-14 |
| 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 | 2015-01-14 |
| Model Number | NA |
| Catalog Number | 04499069190 |
| Lot Number | 69390101 |
| 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 | 2015-01-14 |