MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-09-05 for INTEGRA BENZODIAZEPINE 737984 manufactured by Roche Diagnostics.
[210512]
Benzodiazepine semi-quantitative assay gave a negative result, but retest with gcms gave a result of 53,000 ng/ml of lorazepam.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2001-00182 |
| MDR Report Key | 350577 |
| Report Source | 05 |
| Date Received | 2001-09-05 |
| Date of Report | 2001-08-23 |
| Date of Event | 2001-07-27 |
| Date Mfgr Received | 2001-07-27 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2001-09-12 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DEBARA REEK |
| Manufacturer Street | 9115 HAGUE RD. |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175763857 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGRA BENZODIAZEPINE |
| Generic Name | IN-VITRO DIAGNOSTIC REAGENT |
| Product Code | JXM |
| Date Received | 2001-09-05 |
| Model Number | NA |
| Catalog Number | 737984 |
| Lot Number | 157199 |
| ID Number | NA |
| Device Expiration Date | 2002-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 339872 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE RD. INDIANAPOLIS IN 46250 US |
| Baseline Brand Name | INTEGRA BENZODIAZEPINE |
| Baseline Generic Name | NA |
| Baseline Model No | NA |
| Baseline Catalog No | 737984 |
| Baseline ID | NA |
| Baseline Device Family | INTEGRA FAMILY OF ANALYZERS |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K951595 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-09-05 |