MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2015-10-08 for COBAS INTEGRA BENZODIAZEPINES 20737984122 manufactured by Roche Diagnostics.
[27818284]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[27818305]
The customer received questionable false negative benzodiazepines results for two samples from one patient from the integra 800 analyzer serial number (b)(4). The customer used a cut off value of 200. The first sample from the patient was tested on (b)(6) 2015 and reported as 73 (negative). The physician requested another sample on (b)(6) 2015 and the result was 177 (negative). The physician questioned the results and asked that the customer send samples from the patient out for confirmation. The results by gc/ms were positive. Refer to the attachment to the medwatch for the specific results. All of the results were reported outside the laboratory. The patient was not adversely affected. It was noted the calibration performed prior to the first questionable result was performed using expired calibrator material.
Patient Sequence No: 1, Text Type: D, B5
[36866569]
A specific root cause could not be identified. An unknown interference was suspected to be in the sample.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-04294 |
| MDR Report Key | 5135002 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-10-08 |
| Date of Report | 2016-01-26 |
| Date of Event | 2015-08-26 |
| Date Mfgr Received | 2015-09-23 |
| Date Added to Maude | 2015-10-08 |
| 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 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 INTEGRA BENZODIAZEPINES |
| Generic Name | ENZYME IMMUNOASSAY, BENZODIAZIPINE |
| Product Code | JXM |
| Date Received | 2015-10-08 |
| Model Number | NA |
| Catalog Number | 20737984122 |
| Lot Number | 60194801 |
| ID Number | NA |
| Device Expiration Date | 2016-01-31 |
| 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 | 2015-10-08 |