MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2015-12-14 for COBAS BENZODIAZEPINES 04780248190 manufactured by Roche Diagnostics.
[33429139]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[33429140]
The customer received false negative benzodiazepine plus results in urine that were confirmed to be positive with lc/ms. No specific data or date of event was provided. It was unknown if any erroneous result was reported outside of the laboratory. There was no adverse event. The analyzer involved in the event was a cobas integra 400 plus serial number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[35777496]
Data was provided for five patient samples. It was found the calibration for lot 608892 had a lower curve than the previous lot. According to the customer, the qc results were good but the patient results were significantly lower.
Patient Sequence No: 1, Text Type: N, H10
[37070795]
A specific root cause could not be determined. Retention material of the same lot of reagent was tested and the results were within specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-06028 |
| MDR Report Key | 5294606 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-12-14 |
| Date of Report | 2016-01-27 |
| Date of Event | 2015-11-27 |
| Date Mfgr Received | 2015-11-27 |
| Date Added to Maude | 2015-12-14 |
| 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 | 3 |
| 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 |
| 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 | 2015-12-14 |
| Model Number | NA |
| Catalog Number | 04780248190 |
| Lot Number | 608892 |
| ID Number | NA |
| 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 | 2015-12-14 |