FDA Adverse Event
Malfunction
Summary report: N
I-STAT PT/INR CARTRIDGE
MDR report key: 2512727
·
Received March 28, 2012
Report
- Report Number
- 2245578-2012-00196
- Event Type
- Malfunction
- Date Received
- March 28, 2012
- Date of Event
- December 2, 2011
- Report Date
- March 14, 2012
- Manufacturer
- ABBOTT POINT OF CARE, INC.
- Product Code
- GJS
- PMA / PMN Number
- K020355
- Removal / Correction Number
- APOC2012-003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN INVESTIGATION WAS COMPLETED ON 03/14/2012 AND A DEFICIENCY WAS IDENTIFIED. (B)(4). DETAILS WERE PROVIDED WITH THE ACTION THAT WAS CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION.
Description of Event or Problem · 1
ON (B)(4) 2012, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING PT/INR CARTRIDGES THAT YIELDED A DISCREPANT PT/INR RESULTS USING TWO LOTS OF CARTRIDGES ON ONE ANALYZER. THE CUSTOMER DID NOT PROVIDE ANY PT INFORMATION, NOR ANY TEST RESULTS. LOT #: R11232A, MANUFACTURE DATE: 08/2011; EXPIRATION DATE: 02/14/2012. BASED ON THE INFORMATION AVAILABLE AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | I-STAT PT/INR CARTRIDGE | PT/INR CARTRIDGE | GJS | ABBOTT POINT OF CARE, INC. | NA | R11272B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |