MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-09-18 for COBAS INTEGRA ALKALINE PHOSPHATASE 0766739 manufactured by Roche Diagnostics.
[198874]
The customer loaded and ran one reagent cassette on one analyzer. The customer then took this reagent cassette off of this analyzer and loaded onto another analyzer and ran several pt samples. The analyzer recognized this cassette as a new reagent cassette. 7 patient samples recovered falsely zero. No results were reported for pt treatment. Samples were return. These values were reported for pt treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2000-00194 |
| MDR Report Key | 297158 |
| Report Source | 05 |
| Date Received | 2000-09-18 |
| Date of Report | 2000-09-12 |
| Date of Event | 2000-03-14 |
| Date Mfgr Received | 2000-03-14 |
| Device Manufacturer Date | 1999-08-01 |
| Date Added to Maude | 2000-09-25 |
| 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 | COBAS INTEGRA ALKALINE PHOSPHATASE |
| Generic Name | LABORATORY CLINICAL CHEMISTRY CASSETTE |
| Product Code | CJE |
| Date Received | 2000-09-18 |
| Model Number | NA |
| Catalog Number | 0766739 |
| Lot Number | 61013501 |
| ID Number | NA |
| Device Expiration Date | 2001-04-30 |
| 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 | 287636 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD INDIANAPOLIS IN 46250 US |
| Baseline Brand Name | COBAS INTEGRA ALKALINE PHOSPHATASE |
| Baseline Generic Name | LABORATORY CLINICAL CHEMISTRY CASSETTE |
| Baseline Model No | NA |
| Baseline Catalog No | 0766739 |
| Baseline ID | NA |
| Baseline Device Family | INTEGRA FAMILY OF ANALYZERS |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K981897 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-09-18 |