MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-10 for ONLINE DAT BENZODIAZEPINES PLUS 04490789190 manufactured by Roche Diagnostics.
[16913508]
The customer received questionable results for benzodiazepines plus (benz) on one patient sample. The initial benz result was negative using the qualitative 200 ng/ml cutoff screening test. The result was reported outside of the laboratory. The sample was sent to a reference laboratory and was tested by gas chromatography/mass spectrometry (gc/ms) and generated a result of 1557 ng/ml lorazepam in the sample. The customer deemed the gc/ms result to be the correct result. There was no adverse event. The lot number for the benz reagent in use was 68216501, with an expiration date of 01/31/2015. The field service representative found the gear pump pressure was low. He adjusted the pressure to specification. He performed mechanism checks, which passed. The customer performed calibration and qc successfully.
Patient Sequence No: 1, Text Type: D, B5
[16966691]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[18763948]
The investigation determined that lorazepam metabolites have a 0. 5% cross reactivity with the benz assay. Since lorazepam metabolites are frequently present in the urine, the assay will not detect it with the found concentration. This is indicated in the product labeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-01673 |
| MDR Report Key | 3670532 |
| Report Source | 05,06 |
| Date Received | 2014-03-10 |
| Date of Report | 2014-03-21 |
| Date of Event | 2014-02-19 |
| Date Mfgr Received | 2014-02-27 |
| Date Added to Maude | 2014-03-10 |
| 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 | 2014-03-10 |
| Model Number | NA |
| Catalog Number | 04490789190 |
| Lot Number | 68216501 |
| ID Number | NA |
| Device Expiration Date | 2015-01-31 |
| 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 | 2014-03-10 |