MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-06 for COBAS BENZODIAZEPINES 04490789190 manufactured by Roche Diagnostics.
[4201053]
The customer received false positive benzodiazepine results for several patient urine samples. The customer did not know which analyzer was used for testing, but stated cobas c501 serial number (b)(4) was normally used for all dat (drugs of abuse) testing the specific number was samples affected was unknown. Of the data provided for two patients, only the results for one patient were discrepant. The patient had three separate urine samples collected from the er. Sample 1 was tested on (b)(6) 2014, sample 2 was tested on (b)(6) 2014 and sample 3 was tested on (b)(6) 2014. All were reported as positive for benzodiazepine. All three samples were then frozen and sent for gc/ms on (b)(6) 2014. The results for all three samples were "none detected" for benzodiazepine. The positive results were reported outside the laboratory. The gc/ms results were believed to be correct. The customer did not know of any affects to any patient. The customer refused a service visit.
Patient Sequence No: 1, Text Type: D, B5
[11578036]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[11666137]
Additional information was received from the customer clarifying the data previously reported from one patient was actually from three separate patients. Refer to the attachment to the medwatch for patient demographics, medications and diagnoses.
Patient Sequence No: 1, Text Type: N, H10
[11775869]
The investigation determined the positive results for three of the patient samples could be from cross-reactivity to medication being given to the patients. The medication cross reactivity with the assay is listed in product labeling. A specific root cause could not be identified for the positive result for the patient with birthdate (b)(6). Most probably, an unknown substance is cross-reacting with the assay.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-01599 |
| MDR Report Key | 3664583 |
| Report Source | 05,06 |
| Date Received | 2014-03-06 |
| Date of Report | 2014-04-24 |
| Date of Event | 2014-01-06 |
| Date Mfgr Received | 2014-02-11 |
| Date Added to Maude | 2014-03-06 |
| 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 | 2014-03-06 |
| 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 | 2014-03-06 |