MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-08-15 for IMX STAT CK-MB REAGENT 7A28-20 manufactured by Abbott Health Products, Inc..
[68610]
At 0200 on 7/16/1997 the account obtained a ck-mb result=20. 3 ng/ml. The account had not run control on this carousel. 8-10 hours later the account respun the sample and tested for a result=2. 6 ng/ml. The account had reported the initial test result of 20. 3 ng/ml to the diagnosing physician who administered retavase. The on-call physician noted ekg looked like evolving inferior mi. The pt has since been back to the dr's office and is stable.
Patient Sequence No: 1, Text Type: D, B5
[7761893]
Add'l info: sections d5, d6 (lot number), and h4. Corrected info and data: sections h3 and h6 (eval codes for method, results, and conclusions). Code 81: suspected fibrin clot in the specimen due to elevated clotting time. An investigation is in progress. A final report will contain further info with a final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2623532-1997-00022 |
| MDR Report Key | 113876 |
| Report Source | 06 |
| Date Received | 1997-08-15 |
| Date of Report | 1997-08-15 |
| Date of Event | 1997-07-17 |
| Date Mfgr Received | 1997-07-17 |
| Device Manufacturer Date | 1997-03-01 |
| Date Added to Maude | 1997-08-20 |
| 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 | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMX STAT CK-MB REAGENT |
| Generic Name | MEIA FOR THE MEASUREMENT OF CK-MB |
| Product Code | JHY |
| Date Received | 1997-08-15 |
| Model Number | NA |
| Catalog Number | 7A28-20 |
| Lot Number | 27630Q100 |
| ID Number | NA |
| Device Expiration Date | 1997-11-27 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 111790 |
| Manufacturer | ABBOTT HEALTH PRODUCTS, INC. |
| Manufacturer Address | KM 58.0 CARRETERA 2 CRUCE DAVILA BARCELONETA PR 00617 US |
| Baseline Brand Name | IMX STAT CK-MB REAGENT PACK |
| Baseline Generic Name | MEIA FOR THE MEASUREMENT OF CK-MB |
| Baseline Model No | NA |
| Baseline Catalog No | 7A28-20 |
| Baseline ID | NA |
| Baseline Device Family | IMX STAT CK-MB |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 11 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K931172 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-08-15 |