FDA Adverse Event
Malfunction
Summary report: N
I-STAT TROPONIN (CTNI) CARTRIDGE
MDR report key: 2199799
·
Received August 2, 2011
Report
- Report Number
- 2245578-2011-00126
- Event Type
- Malfunction
- Date Received
- August 2, 2011
- Date of Event
- July 11, 2011
- Report Date
- August 2, 2011
- Manufacturer
- ABBOTT POINT OF CARE CANADA LTD.
- Product Code
- MMI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 CARTRIDGES THAT ARE YIELDING DISCREPANT RESULTS IN THE ED USING MULTIPLE ANALYZERS. ON (B)(6) 2011 12:53 RESULT: 0.04 NG/ML. ON (B)(6) 2011 12:58 RESULT: 0.06 NG/ML. ON (B)(6) 2011 13:15 RESULT: 0.14 NG/ML. SAMPLE WAS RURN IN THE MAIN LAB. ON (B)(6) 2011 12:23 RESULT: 0.05 NG/ML. THE SUSPECTED DISCREPANT RESULTS WERE NOT RELEASED TO THE PHYSICIAN OR CAREGIVER. 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 TROPONIN (CTNI) CARTRIDGE | CTNI CARTRIDGE | MMI | ABBOTT POINT OF CARE CANADA LTD. | NA | T11096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |