FDA Adverse Event
Malfunction
Summary report: N
AXSYM CK-MB
MDR report key: 1613620
·
Received February 24, 2010
Report
- Report Number
- 1628664-2010-00095
- Event Type
- Malfunction
- Date Received
- February 24, 2010
- Date of Event
- February 11, 2010
- Report Date
- February 11, 2010
- Manufacturer
- ABBOTT LABORATORIES
- Product Code
- JHW
- PMA / PMN Number
- K935924
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER STATES THAT A SAMPLE FROM ONE PATIENT PROCESSED USING THE AXSYM CK MB ASSAY GENERATED A FALSELY DECREASED RESULT. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED RELATED TO THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AXSYM CK-MB | FOR THE QUANTITATIVE DETERMINATION OF THE MB ISOENZYME OF CREATINE KINASE | JHW | ABBOTT LABORATORIES | 83465Q100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | AXSYM ANALYZER LN 7A83-01, (B)(4)| AXSYM CKMB RGT LN 7K47-20, LOT # 83465Q100 |