MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-10-27 for IMX STAT CK-MB REAGENT 7A28-20 manufactured by Abbott Health Products, Inc..
[77446]
On 9/25/1997 the account reported a falsely elevated ck-mb result of 15. 1 ng/ml on a patient, who had a previous ck-mb result of 2. 6 ng/ml. A third sample on the patient gave a result of 1. 5 ng/ml. The second result was questioned by the technician running the third sample and the second sample was retested, giving a result of 2. 5 ng/ml. The second sample was serum and had clotted between the original run and the retest. The account believes the second sample may have clotted in the sample cup during the original run. The patient was not treated based upon the falsely elevated result. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
[15137851]
Complaint evaluation: a customer return was not received. In order to investigate this complaint, a calibration curve was run followed by a mode-1 run, using the same reagent as the customer. This was performed on one imx to determine if any controls or panels were elevated. A summary of the investigation indicated all controls and panel values were within the package insert ranges. All of the panel values were within the in-house specifications. No corrective action is necessary. This is the final report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2623532-1997-00024 |
| MDR Report Key | 129180 |
| Report Source | 05,06 |
| Date Received | 1997-10-27 |
| Date of Report | 1997-10-24 |
| Date of Event | 1997-09-25 |
| Date Mfgr Received | 1997-09-26 |
| Device Manufacturer Date | 1997-03-01 |
| Date Added to Maude | 1997-11-03 |
| 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 | 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 | 1997-10-27 |
| Model Number | NA |
| Catalog Number | 7A28-20 |
| Lot Number | 27630Q100 |
| ID Number | NA |
| Device Expiration Date | 1997-11-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 126364 |
| 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 | 1997-10-27 |