FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 2078540
·
Received April 26, 2011
Report
- Report Number
- 2027969-2011-00930
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- March 31, 2011
- Report Date
- April 26, 2011
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K021923
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING. ADD'L LOT#: 240540.
Description of Event or Problem · 1
CUSTOMER STATED THE FIELD NURSE RETURNED THE INR2 METER (B)(6), BECAUSE IT IS GIVING DISCREPANT RESULTS ON MORE THAN 1 PT (3-4) COMPARED WITH THE LAB. RESULTS AS FOLLOWS: DATE: (B)(6) 2011, INRATIO2: 7.5, LAB: 3.5, 4.0. ON (B)(6) 2011, FIELD NURSE (B)(6) CALLED TO CLARIFY THE DISCREPANCIES. SHE STATED THAT INRATIO2 METER IS GIVING HIGH RESULTS LIKE 7.5 YET THE LAB DRAWS ARE COMING BACK AS 3.5 AND 4.0 (FOR 3 OR 4 PTS). SO, BOTH METHODOLOGIES ARE GIVING RESULTS THAT ARE ELEVATED FOR EACH PT AND THAT THE COUMADIN WAS HELD FOR THE NIGHT BASED ON LAB DRAW RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 237433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |