FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 1982543
·
Received January 11, 2011
Report
- Report Number
- 2027969-2011-00076
- Event Type
- Malfunction
- Date Received
- January 11, 2011
- Date of Event
- December 21, 2010
- Report Date
- January 11, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
"CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS:" 3.8, 2.9. FIRST READING WAS A 3.8, REPEAT, WITHIN MINS WAS A 2.9. CUSTOMER CALLED IN AFTER HER MACHINE WAS APPARENTLY STUCK IN WARM-UP. WOULD NOT GIVE A RESULT FOR OVER TEN MINS. SHE TRIED REMOVING THE STRIP AND PUNCHING BUTTONS, BUT IT WOULD NOT RESPOND. AFTER CHANGING BATTERIES, PT GOT A 3.8. PT STATED THAT HER RANGE WAS BETWEEN 2-3 AND THAT SHE HAD NEVER BEEN SO HIGH. PT HAD DONE FINGERSTICK ON SAME FINGER AS SHE USED BEFORE CALLING. WHEN SHE USED A NEW FINGER FOR FINGERSTICK, HER RESULT WAS 2.9.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | NG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |