FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 3802332
·
Received February 20, 2014
Report
- Report Number
- 2027969-2014-00151
- Event Type
- Malfunction
- Date Received
- February 20, 2014
- Date of Event
- January 28, 2014
- Report Date
- February 4, 2014
- Manufacturer
- ALERE SAN DIEGO, INC
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER DID NOT PROVIDE LOT NUMBERS OR RETURN PRODUCTS FOR INVESTIGATION. UNABLE TO PERFORM FURTHER INVESTIGATION WITHOUT ADD'L INFO. RESULTS OF THE QUERY OF SIMILARLY INCIDENTS IN THE COMPLAINT SYSTEM FOR THIS TREND CODE DID NOT INDICATE A MANUFACTURING ISSUE. ROOT CAUSE COULD NOT BE DUPLICATED FROM THE INFO PROVIDED BY THE CUSTOMER. THE ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME, AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.
Description of Event or Problem · 1
CALLER ALLEGING DISCREPANT LOW INRATIO READING (B)(6) 2014 INRATIO: 1.4, LAB: 2.3. TIME BETWEEN TESTS: ONE HOUR. PATIENT'S THERAPEUTIC RANGE 2-3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106503 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC | 100071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | ORAL ANTICOAGULANTS COUMADIN |