MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-03-25 for IMX STAT CK-MB REAGENT 7A28-20 manufactured by Abbott Health Products, Inc..
[52225]
On 2/23 a patient's blood was drawn and a result of 12. 1 was reported out using the ck-mb assay. The test was repeated when questioned and the result was. 4 for ck-mb. The patient's blood was drawn again on 2/24 and the result of 5. 2 was reported. The test was repeated and the result was. 9. On both days the account issued a corrected report. The results did not affect treatment of patient. The patient was admitted with chest pain. The reporter does not have access to any other diagnostic test and does not know status of patient except that he has been discharged. The account stated the fpia buffer is >1 year and is out of date.
Patient Sequence No: 1, Text Type: D, B5
[18592042]
Investigation summary: file samples of reagents were with customer returned patient samples used for the investigation. Erratic results were not observed on controls, panels, or patient sample draws. All values were within package insert range for the controls. This complaint is not confirmed. Evaluation complete-final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2623532-1997-00007 |
| MDR Report Key | 80773 |
| Report Source | 05 |
| Date Received | 1997-03-25 |
| Date of Report | 1997-03-25 |
| Date of Event | 1997-02-23 |
| Date Mfgr Received | 1997-02-24 |
| Device Manufacturer Date | 1996-12-01 |
| Date Added to Maude | 1997-04-04 |
| 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 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 1997-03-25 |
| Model Number | NA |
| Catalog Number | 7A28-20 |
| Lot Number | 24611Q100 |
| ID Number | NA |
| Device Expiration Date | 1997-07-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 80234 |
| Manufacturer | ABBOTT HEALTH PRODUCTS, INC. |
| Manufacturer Address | KM 58.0 CARRETERA 2 CRUCE DAVILA BARCELONETA PR 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 | 1997-03-25 |