MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-07-14 for IMX STAT CK-MB REAGENT 7A28-20 manufactured by Abbott Health Products, Inc..
[103765]
On 06/11/1998 the account reported a ck-mb result of 28. 9 ng/ml on serum specimen drawn at 23:00 pm. The pt was given heparin and admitted to the hosp for observation. A second specimen was drawn at 06:20 am on 06/12/1998 and a result of 3. 8 ng/ml was obtained. The specimen from 23:00 pm on 06/11/1998 was retested and a result of 3. 5 ng/ml was obtained. A heparinized plasma sample from 23:00 pm on 06/11/1998 was also tested and a result of 4. 1 ng/ml was obtained. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2623532-1998-00003 |
| MDR Report Key | 177464 |
| Report Source | 06 |
| Date Received | 1998-07-14 |
| Date of Report | 1998-07-10 |
| Date of Event | 1998-06-11 |
| Date Mfgr Received | 1998-06-12 |
| Device Manufacturer Date | 1998-04-01 |
| Date Added to Maude | 1998-07-17 |
| 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 | 1998-07-14 |
| Model Number | NA |
| Catalog Number | 7A28-20 |
| Lot Number | 40772Q100 |
| ID Number | NA |
| Device Expiration Date | 1999-02-05 |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 172563 |
| Manufacturer | ABBOTT HEALTH PRODUCTS, INC. |
| Manufacturer Address | KM 58.0, CARRETERA 2 BARCELONETA PR 00617 US |
| Baseline Brand Name | IMX STAT CK-MB RGT |
| 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 | 1998-07-14 |