MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-03-27 for AMMONIA REAGENT * 0766682, 0766685, 0737453 manufactured by Roche Diagnostics.
[20468981]
Recent data from a customer site has shown sample-dependent lower recovery with heparin plasma when using the suspect reagent on the analyzers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2000-00057 |
| MDR Report Key | 271657 |
| Report Source | 05 |
| Date Received | 2000-03-27 |
| Date of Report | 2000-03-17 |
| Date of Event | 1999-12-30 |
| Date Mfgr Received | 2000-03-17 |
| Date Added to Maude | 2000-04-03 |
| 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 | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMMONIA REAGENT |
| Generic Name | CLINICAL CHEMISTRY REAGENT |
| Product Code | JIF |
| Date Received | 2000-03-27 |
| Returned To Mfg | 1999-12-30 |
| Model Number | * |
| Catalog Number | 0766682, 0766685, 0737453 |
| Lot Number | B2434, B2635, 60563501 |
| ID Number | * |
| Device Expiration Date | 2000-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 262976 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE RD. INDIANAPOLIS IN 46250 US |
| Baseline Brand Name | AMMONIA REAGENT |
| Baseline Generic Name | CLINICAL CHEMISTRY REAGENT |
| Baseline Model No | * |
| Baseline Catalog No | 0766682, 0766685, 0737453 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-03-27 |