FDA Adverse Event
Malfunction
Summary report: N
CX GLUCOSE REAGENT
MDR report key: 2438830
·
Received February 3, 2012
Report
- Report Number
- 2050012-2012-00361
- 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
- K883181
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(4) 2012, CUSTOMER REPORTED THAT SHE RECEIVED A GLUCOSE REAGENT CARTRIDGE THAT HAD LEAKED DUE TO A LOOSE CAP. NO EXPOSURE OR INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. BECKMAN COULTER SENT A REPLACEMENT CARTRIDGE TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CX GLUCOSE REAGENT | HEXOKINASE, GLUCOSE | CKA | BECKMAN COULTER, INC. | M110253 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |