MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-22 for IMX SYSTEM CA 19 REAGENT manufactured by Abbott Labs.
[17192]
During pilot of 100 ca 19-9 serum tumor marker assays done with a kit produced by mfr, results were compared with those of a reference lab utilizing radio immunoassay. Kit results were 65% higher than immunoassay. Mfr recalibrated and redistributed the kit. By error and unbeknownst to rptr, a batch of old kits, distinguished from the new kits by only a single number in the product code, were sent to rptr, assays were done 3/15/95-3/21/95, when mfr notified rptr of the error. Twenty four pts were identified as having been tested. Their physicians were notified. No treatment plans were changed based on the tests and there were no injuries. Mfr has replaced kits.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1006031 |
| MDR Report Key | 21931 |
| Date Received | 1995-05-22 |
| Date of Report | 1995-05-12 |
| Date of Event | 1995-03-15 |
| Date Added to Maude | 1995-05-25 |
| 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 | IMX SYSTEM |
| Generic Name | TUMOR MARKER ASSAY |
| Product Code | LCI |
| Date Received | 1995-05-22 |
| Model Number | CA 19 REAGENT |
| Operator | OTHER |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 21996 |
| Manufacturer | ABBOTT LABS |
| Manufacturer Address | ABBOTT PARK IL 60064 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-05-22 |