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 2016-12-20 for BENZ BENZODIAZEPINES 20737984122 manufactured by Roche Diagnostics.
[62803103]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[62803104]
The customer received questionable benz benzodiazepines results for one patient from cobas integra 400 plus serial number (b)(4). The urine result was negative and was reported outside the laboratory. The customer used a value of 200 for the cutoff point for the assay. As the patient was on lorazepam and the result was expected to be positive, the physician asked for confirmation testing. The customer sent the sample for confirmation testing by gc/ms and the result was 1074 ng/ml (positive). The result by gc/ms was believed to be correct. On (b)(6) 2016, the customer repeated the same sample on the cobas integra 400 plus and the result was again negative. The patient was not adversely affected. The customer refused a service visit to check the analyzer.
Patient Sequence No: 1, Text Type: D, B5
[65686471]
Based on the information provided, a specific root cause could not be determined. As the sample in question was not available, further investigation was not possible. Additional information for further investigation was requested but was not provided. It was suspected a substance in the sample was interfering with the assay. Calibration and qc data were acceptable and did not indicate any reagent issue and confirmed the assay was performing within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-02018 |
| MDR Report Key | 6188420 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-12-20 |
| Date of Report | 2017-01-13 |
| Date of Event | 2016-12-05 |
| Date Mfgr Received | 2016-12-08 |
| Date Added to Maude | 2016-12-20 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| 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 | BENZ BENZODIAZEPINES |
| Generic Name | ENZYME IMMUNOASSAY, BENZODIAZEPINE |
| Product Code | JXM |
| Date Received | 2016-12-20 |
| Model Number | NA |
| Catalog Number | 20737984122 |
| Lot Number | ASKU |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-20 |