MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-11-10 for ALT (SGPT) TEST SLIDE CARTRIDGE PACK 10-109-7957 manufactured by Eastman Kodak Co..
[13050]
Original (incorrect) alt result was sent to floor on a pt. After several pts were assayed with the same low results, controls were run on alt and also found to be low. Alt cartridge was replaced with another one of the same lot #. Controls were run and were satisfactory. Pt alt was rerun on slides from new cartridge and correct result was transmitted to the floor. No explanation or determination made of why the one alt cartridge produced erroneous alt results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003979 |
| MDR Report Key | 17563 |
| Date Received | 1994-11-10 |
| Date of Report | 1994-10-24 |
| Date of Event | 1994-10-04 |
| Date Added to Maude | 1994-11-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALT (SGPT) TEST SLIDE CARTRIDGE PACK |
| Generic Name | TEST SLIDE CARTRIDGE |
| Product Code | CJJ |
| Date Received | 1994-11-10 |
| Catalog Number | 10-109-7957 |
| Lot Number | 7957 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17484 |
| Manufacturer | EASTMAN KODAK CO. |
| Manufacturer Address | ROCHESTER NY 14650 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-11-10 |