FDA Adverse Event
Other
Summary report: N
I-STAT CTNI CARTRIDGE
MDR report key: 906931
·
Received August 31, 2007
Report
- Report Number
- 2245578-2007-00030
- Event Type
- Other
- Date Received
- August 31, 2007
- Date of Event
- August 2, 2007
- Report Date
- August 31, 2007
- Manufacturer
- ABBOTT POINT OF CARE INC.
- Product Code
- MMI
- PMA / PMN Number
- K031739
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IN 2007, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ON PREVIOUS DAY, MULITPLE SAMPLES FROM ONE PT REPEATEDLY GENERATED CODE 149 ON THE I-STAT CARDIAC TROPONIN I CARTRIDGE; NO RESULT WAS GENERATED. ON THE NEXT DAY AT 7AM, AN I-STAT CARDIAC TROPONIN I CARTRIDGE YIELDED A RESULT OF <0.01 NG/ML ON THE SAME PT. THE DELAY IN OBTAINING RESULTS HAS THE POTENTIAL TO IMPACT PT TREATMENT. NO ADDITIONAL INFORMATION WAS AVAILABLE FROM THE CUSTOMER AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | I-STAT CTNI CARTRIDGE | IVD | MMI | ABBOTT POINT OF CARE INC. | NA | U07078B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other |