FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 812436
·
Received January 26, 2007
Report
- Report Number
- 2954730-2007-00044
- Event Type
- Malfunction
- Date Received
- January 26, 2007
- Date of Event
- January 19, 2007
- Report Date
- January 26, 2007
- Manufacturer
- HEMOSENSE, INC.
- Product Code
- JPA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
INRATIO PRECISION DATA PROVIDED BY END-USER LOT 060570: FIRST TEST INR = 4.4. SECOND TEST INR = 3.7, MEAN = 4.05; SD = 0.49; %CV = 12%. THE %CV IS LESS THAN OR EQUAL TO 20%. PER INTERNAL PROCEDURE, THE PRECISION PASSES THE CRITERIA FOR PRECISION. THE TEST IS CONSIDERED PRECISE AND NO FURTHER TESTING IS REQUIRED AT THIS TIME.
Description of Event or Problem · 1
CALLER ALLEGED IMPRECISION WITH INRATIO METER. RESULTS AS FOLLOWS: FIRST TEST INR = 4.4. SECOND TEST INR = 3.7.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | JPA | HEMOSENSE, INC. | * | 060570 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |