FDA Adverse Event
Malfunction
Summary report: N
I-STAT TROPONIN (CTNI) CARTRIDGE
MDR report key: 2390599
·
Received December 19, 2011
Report
- Report Number
- 2245578-2011-00408
- Event Type
- Malfunction
- Date Received
- December 19, 2011
- Date of Event
- December 7, 2011
- Report Date
- December 13, 2011
- Manufacturer
- ABBOTT POINT OF CARE, INC.
- Product Code
- MMI
- PMA / PMN Number
- K031739
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGE THAT YIELDED DISCREPANT RESULTS OF 0.10 ON A PT. SAMPLE COLLECTION: (B)(6) 2011, 15:11, SAMPLE A: 0.1 NG/ML. (B)(6) 2011, 15:36 REPEAT SAMPLE A: 0.05 NG/ML. (B)(6) 2011, 15:57 REPEAT SAMPLE A: 0.05 MG/ML. NO LAB METHOD TESTING PERFORMED. THE CUSTOMER STATES THAT NO CARTRIDGES WILL BE RETURNED FOR INVESTIGATION. 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 | U11241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |