FDA Adverse Event
Malfunction
Summary report: N
I-STAT TROPONIN (CTNI) CARTRIDGE
MDR report key: 2417511
·
Received January 10, 2012
Report
- Report Number
- 2245578-2012-00011
- Event Type
- Malfunction
- Date Received
- January 10, 2012
- Date of Event
- December 21, 2011
- Report Date
- December 22, 2011
- Manufacturer
- ABBOTT POINT OF CARE INC.
- Product Code
- MMI
- PMA / PMN Number
- K031739
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(4) 2011, ABBOTT PONT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED DISCREPANT RESULT OF 0.22 ON A PT WITH LOT U11195. SAMPLE COLLECTION: (B)(6) 2011, 08:45. SAMPLE TESTING: (B)(6) 2011, 09:00 I-STAT CTNI LOT U11259 0.03; (B)(6) 2011, 09:10 I-STAT CTNI FOR U11195 0.22. CUSTOMER STATES THAT THE PHYSICIAN USED THE CTNI VALUE OF 0.03 FOR PT TREATMENT AS THERE WAS NO CARDIAC. BASED ON THE INFO 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 TROPONIN (CTNI) CARTRIDGE | CTNI CARTRIDGE | MMI | ABBOTT POINT OF CARE INC. | NA | U11195 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |