FDA Adverse Event
Malfunction
Summary report: N
I-STAT PT/INRCARTRIDGE
MDR report key: 4170527
·
Received October 14, 2014
Report
- Report Number
- 2245578-2014-00072
- Event Type
- Malfunction
- Date Received
- October 14, 2014
- Date of Event
- September 19, 2014
- Report Date
- September 19, 2014
- Manufacturer
- ABBOTT POINT OF CARE
- Product Code
- GJS
- PMA / PMN Number
- K020355
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INVESTIGATION WAS COMPLETED ON 12/10/2014. RETAIN AND RETURNED CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
N/A
Description of Event or Problem · 1
ON (B)(6) 2014, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED UNEXPECTED RESULTS ON I-STAT PT/INR ON A (B)(6) MALE PATIENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. THE CUSTOMER STATES THAT RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. TEST DATE TIME RESULT SAMPLE(B)(6) 2014 12:10 AM 4.3 A(B)(6) 2014 12:18 AM 2.3 B(B)(6) 2014 12:29 AM 2.4 CBASED 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 |
|---|---|---|---|---|---|---|---|
| 651650 | I-STAT PT/INRCARTRIDGE | PT/INR CARTRIDGE | GJS | ABBOTT POINT OF CARE | NA | T14170D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR |