FDA Adverse Event
Malfunction
Summary report: N
ALT (ALANINE AMINOTRANSFERASE) IFCC
MDR report key: 2438831
·
Received February 3, 2012
Report
- Report Number
- 2050012-2012-00362
- Event Type
- Malfunction
- Date Received
- February 3, 2012
- Date of Event
- January 18, 2012
- Report Date
- January 18, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- CKA
- PMA / PMN Number
- K952427
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(4) 2012, CUSTOMER REPORTED THAT 2 CARTRIDGES OF ALANINE AMINOTRANSFERASE (ALT) REAGENT WERE LEAKING UPON ARRIVAL AND APPEARED TO HAVE A DEFECT ALONG THE BOTTOM SEAM OF THE CARTRIDGE. NO EXPOSURE OR INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. IT WAS DECIDED THAT AN MDR SHOULD BE FILED BECAUSE THE REAGENT CONTAINS MATERIAL OF ANIMAL ORIGIN THAT IS POTENTIALLY INFECTIOUS, AND UPON RECUR, EXPOSURE COULD RESULT IN SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALT (ALANINE AMINOTRANSFERASE) IFCC | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | CKA | BECKMAN COULTER, INC. | T106012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |