MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-10-05 for INTEGRA ETHANOL 20752401190 manufactured by Roche Diagnostics.
[477238]
Patient ethanol samples gave lower results as they got to the end of their reagent cassette. The field service representative found the cassette was defective and corrected the low results by replacing the cassette. The incorrect results were not used to guide therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2005-02031 |
| MDR Report Key | 691285 |
| Report Source | 05 |
| Date Received | 2005-10-05 |
| Date of Report | 2005-02-01 |
| Date of Event | 2005-02-01 |
| Date Mfgr Received | 2005-02-01 |
| Date Added to Maude | 2006-03-27 |
| 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 | CHRISTOF LITTWITZ |
| Manufacturer Street | 9115 HAGUE ROAD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDOFER STRASSE 116 |
| Manufacturer City | MANNHEIM D-68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-68305 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTEGRA ETHANOL |
| Generic Name | CLINICAL CHEMISTRY REAGENT |
| Product Code | DIC |
| Date Received | 2005-10-05 |
| Model Number | NA |
| Catalog Number | 20752401190 |
| Lot Number | 655150 |
| ID Number | NA |
| Device Expiration Date | 2005-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 680437 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE RD. INDIANAPOLIS IN 46250 US |
| Baseline Brand Name | INTEGRA ETHANOL |
| Baseline Generic Name | CLINICAL CHEMISTRY REAGENT |
| Baseline Model No | NA |
| Baseline Catalog No | 20752401190 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-10-05 |