MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-03 for COBAS BENZODIAZEPINES 04490789190 manufactured by Roche Diagnostics.
[9257475]
The investigation was unable to determine a root cause. The patient sample involved in the event was not returned to the manufacturer for testing. Three different samples from the same patient were provided for investigation. All 3 samples were negative with two different calibrator lots, but were close to the cut off level for the assay. Gc/ms results of the 3 samples returned for investigation were not provided, the negative results on these samples could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[21638032]
The customer alleged questionable, positive urine drugs of abuse (dat) tests on about 20 patient samples tested on the cobas c501 analyzer, (b)(4), when compared to testing done with the triage test system over the last few days. The samples were sent for testing by gas chromatography/mass spectrometry (gc/ms). The customer was then questioning results on 8 samples. Of those, results for 1 sample were provided. The initial benzodiazepines result on the cobas c501 analyzer was positive. The sample was negative for benzodiazepines when analyzed by gc/ms. The patient was not affected by the report of false positive benzodiazepines result. The customer declined a service visit because they did not believe there was an instrument issue.
Patient Sequence No: 1, Text Type: D, B5
[21924744]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-02986 |
| MDR Report Key | 2112401 |
| Report Source | 05,06 |
| Date Received | 2011-06-03 |
| Date of Report | 2011-08-25 |
| Date of Event | 2011-05-06 |
| Date Mfgr Received | 2011-05-17 |
| Date Added to Maude | 2011-06-03 |
| 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 RAE ANN FARROW |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175213194 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| 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 | 2011-06-03 |
| Model Number | NA |
| Catalog Number | 04490789190 |
| Lot Number | 15631200 |
| ID Number | NA |
| Device Expiration Date | 2012-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-06-03 |