MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2011-09-22 for BENZODIAZEPINES 04780248190 manufactured by Roche Diagnostics.
[2162823]
The customer received two questionable benzodiazepines results on their integra 800 analyzer. Patient one received a false positive result for benzodiazepine. Patient two received a false positive result for benzodiazepine the customer confirmed both false positive results using other immunochemical test methods like eia. The samples were further tested by gc/ms in (b)(6) and were found to be negative. It is unknown at this time if the patients were adversely affected by this event. The benzodiazepine reagent lot number was 156314 and the expiration date was (b)(6) 2011. The initial investigation shows there is potentially an unknown interfering substance present in the samples. Clozapine and nevirapine, which were detected on the gc/ms drug screening, show no cross- reactivity with the benzodiazepine assay. Further investigation is ongoing.
Patient Sequence No: 1, Text Type: D, B5
[9328008]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[9949096]
A specific root cause could not be determined. It is probable that there is an interfering substance in the sample. This substance could not be identified with available test methods.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-05038 |
| MDR Report Key | 2260686 |
| Report Source | 01,06,07 |
| Date Received | 2011-09-22 |
| Date of Report | 2012-04-06 |
| Date of Event | 2011-03-28 |
| Date Mfgr Received | 2011-05-20 |
| Date Added to Maude | 2011-09-22 |
| 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 JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 317521-700 |
| 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 | BENZODIAZEPINES |
| Generic Name | ENZYME IMMUNOASSAY, BENZODIAZIPINE |
| Product Code | JXM |
| Date Received | 2011-09-22 |
| Model Number | NA |
| Catalog Number | 04780248190 |
| Lot Number | 156314 |
| ID Number | NA |
| Device Expiration Date | 2011-11-30 |
| 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 | 2011-09-22 |