FDA Adverse Event
Malfunction
Summary report: N
I-STAT PT/INRCARTRIDGE
MDR report key: 4170535
·
Received October 14, 2014
Report
- Report Number
- 2245578-2014-00073
- 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).
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.
Description of Event or Problem · 1
ON 09/19/2014, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER WHO REPORTED UNEXPECTED RESULTS ON I-STAT PT/INR ON A (B)(6) YEAR OLD 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: 9/19/2014, TIME: 11:10 AM, RESULT: 5.1, SAMPLE A; 9/19/2014, 11:21 AM, 2.8, B; 9/19/2014, 11:33 AM, 2.7, C. BASED ON THE INFORMATION AVAILABLE AT THE TIME THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT.
Description of Event or Problem · 1
N/A
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 651112 | I-STAT PT/INRCARTRIDGE | PT/INR CARTRIDGE | GJS | ABBOTT POINT OF CARE | NA | T14170D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |