MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-05-15 for COBAS BENZODIAZEPINES 04490789190 manufactured by Roche Diagnostics.
[21220455]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. It was assumed that the cause of the event was an unknown substance that interfered with the assay. Product labeling states other substances and/or factors may interfere with the test and cause erroneous results. A general reagent or instrument issue was not suspected as the calibration and qc results were acceptable.
Patient Sequence No: 1, Text Type: N, H10
[21562817]
The customer received questionable benzodiazepine plus results for two patient samples. Patient sample 1 was tested on 03/11/2015 and patient sample 2 was tested on (b)(6) 2015. The results from cobas c501 serial number (b)(4) were positive. The samples were sent for confirmation by gas chromatography-mass spectrometry (gc-ms) and the results were negative. No specific data was provided. The positive results were reported outside the laboratory. The results by gc-ms were believed to be correct. The patients were not adversely affected. The customer declined a service visit.
Patient Sequence No: 1, Text Type: D, B5
[21817385]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03469 |
| MDR Report Key | 4776116 |
| Report Source | 05,06 |
| Date Received | 2015-05-15 |
| Date of Report | 2015-06-12 |
| Date of Event | 2015-03-11 |
| Date Mfgr Received | 2015-04-30 |
| Date Added to Maude | 2015-05-15 |
| 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 | COBAS BENZODIAZEPINES |
| Generic Name | ENZYME IMMUNOASSAY, BENZODIAZIPINE |
| Product Code | JXM |
| Date Received | 2015-05-15 |
| Model Number | NA |
| Catalog Number | 04490789190 |
| Lot Number | 60195601 |
| ID Number | NA |
| Device Expiration Date | 2016-04-30 |
| 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 | 2015-05-15 |