FDA Adverse Event
Malfunction
Summary report: N
I-STAT CREA CARTRIDGE
MDR report key: 1635647
·
Received March 10, 2010
Report
- Report Number
- 2245578-2010-00010
- Event Type
- Malfunction
- Date Received
- March 10, 2010
- Date of Event
- February 10, 2010
- Report Date
- March 10, 2010
- Manufacturer
- ABBOTT POINT OF CARE
- Product Code
- CGL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L CATALOG# 06F10-02. ADD'L LOT# A09280A.
Description of Event or Problem · 1
A REMEDIAL ACTION HAS BEEN INITIATED TO NOTIFY CUSTOMERS. ABBOTT POINT OF CARE NOTIFIED THE FDA (B)(4) DISTRICT OFFICE, 02/24/2010 BY TELEPHONE, OF THE REMEDIAL ACTION. ABBOTT POINT OF CARE INC HAS DETERMINED THROUGH INTERNAL REVIEW THAT CERTAIN LOTS OF I-STAT CREA CARTRIDGES MAY GENERATE DEPRESSED RESULTS FOR SAMPLE ABOVE THE NORMAL CREATININE RANGE (>2 MG/DL). OUR INTERNAL STUDIES HAVE SHOWN THAT THERE IS A POTENTIAL FOR DEPRESSED CARTRIDGE RESULTS OF 15% TO 25% AT OR NEAR THE END OF THE LABELED EXPIRY WHEN STORED ABOVE 25 DEGREES CELSIUS FOR TWO WEEKS. AT THE TIME OF THE INVESTIGATION, IT WAS DETERMINED THERE WERE NO COMPLAINTS RELATED TO THEN ABOVE STATED PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | I-STAT CREA CARTRIDGE | CREA CARTRIDGE | CGL | ABBOTT POINT OF CARE | A09279A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |