FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2138893
·
Received May 26, 2011
Report
- Report Number
- 2027969-2011-01171
- Event Type
- Malfunction
- Date Received
- May 26, 2011
- Date of Event
- April 29, 2011
- Report Date
- May 26, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT RESULTS USING THE INRATIO METER: RESULTS AS FOLLOWS: PATIENT SELF TESTER CALLED DURING TRAINING. DATE: (B)(6) 2011, INRATIO: 2.1, LOT #, 243699, COMMENTS: TOOK A LITTLE WHILE TO REGISTER BLOOD; (B)(6) 2011, 1.7, 243934, TOOK EVEN LONGER TO REGISTER BLOOD, HAD TO APPLY EXTRA DROP AS FIRST BIT WENT AROUND SAMPLE WELL; (B)(6) 2011, 2.8, 243934, METER REGISTERED BLOOD RIGHT AWAY. PATIENT TOOK HIS COUMADIN DOSE FOR THE DAY JUST BEFORE DOING THE 1ST TEST. TESTED ON A NEW FINGER EACH TIME; THE 3RD TEST WAS ABOUT 25 MINUTES AFTER THE 1ST TEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 243699 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |