MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-05-18 for IMX STAT CK-MB REAGENT 7A28-66 manufactured by Abbott Health Products, Inc..
[7769396]
Internal identifier(s): 2985215-01 no customer return received. Code 313 - inherent risk of procedure: fibrin clot in sample. Complaint investigation: a file sample of the reagent lot used by the customer, lot number 38066q100, was tested with reference calibrators, reference controls, and ck-mb panels to evaluate assay validity. Ck-mb controls were within package insert ranges. Ck-mb panels were within specification limits, demonstrating that the reagent lot reads pt samples accurately. The complaint was not confirmed. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
[20884462]
On 04/09/1998 the account reported an erratic creatine kinase-myocardial bands result of 5. 4 ng/ml on a pt. The sample was drawn in a lithium heparin tube and was third in a series of creatine kinase-myocardial bands results. The pt presented in the emergency room at the account with chest pain and rec'd heparin therapy in the emergency room. The sample was retested and a corrected result of 24. 7ng/ml was reported on 04/10/1998. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2623532-1998-00002 |
| MDR Report Key | 168614 |
| Report Source | 06 |
| Date Received | 1998-05-18 |
| Date of Report | 1998-05-14 |
| Date of Event | 1998-04-09 |
| Date Mfgr Received | 1998-04-14 |
| Device Manufacturer Date | 1998-02-01 |
| Date Added to Maude | 1998-05-27 |
| 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 | 1998-05-18 |
| Model Number | NA |
| Catalog Number | 7A28-66 |
| Lot Number | 38066Q100 |
| ID Number | NA |
| Device Expiration Date | 1998-09-17 |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 164033 |
| 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 |
| Baseline Generic Name | MEIA FOR THE MEASUREMENT OF CK-MB |
| Baseline Model No | NA |
| Baseline Catalog No | 7A28-66 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-05-18 |