MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-02-10 for COBAS INTEGRA 400 PLUS 3245233001 manufactured by Roche Diagnostics.
[17369255]
Several negative samples of urine tested for benzodiazepine which contained considerable quantities of lorazepam when determined by chromatography. One example provided found 890 ng/ml by chromatography and only 10 ng/ml on this analyzer. Total number of pts involved was not provided. No information was provided to determine if erroneous results were reported or if pts were adversely affected.
Patient Sequence No: 1, Text Type: D, B5
[17667869]
Lorazepam appears in the urine largely as the glucoronidated metabolite. It was noted the lorazepam in the specimen was glucoronidated. Cross reactivity to glucoronidated lorazepam is unknown. If additional information is received, appropriate notification will be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2009-01040 |
| MDR Report Key | 1371284 |
| Report Source | 05,06 |
| Date Received | 2009-02-10 |
| Date of Report | 2009-02-10 |
| Date of Event | 2009-01-20 |
| Date Facility Aware | 2009-01-20 |
| Report Date | 2009-01-20 |
| Date Mfgr Received | 2009-01-20 |
| Date Added to Maude | 2009-09-14 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE RD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | ROCHE INSTRUMENT CENTER AG |
| Manufacturer Street | TEGIMENTA FORRENSTRASSE |
| Manufacturer City | ROTKREUZ 312-8504 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS INTEGRA 400 PLUS |
| Generic Name | CLINICAL CHEMISTRY ANALYZER - JJE |
| Product Code | MGX |
| Date Received | 2009-02-10 |
| Catalog Number | 3245233001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | INDIANAPOLIS IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-02-10 |