FDA Adverse Event
Malfunction
Summary report: N
INTRATIO2 PT/INR PROFESSIONAL TEST STRIPS
MDR report key: 4099078
·
Received September 4, 2014
Report
- Report Number
- 2027969-2014-00813
- Event Type
- Malfunction
- Date Received
- September 4, 2014
- Date of Event
- August 1, 2014
- Report Date
- August 8, 2014
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K110212
- Removal / Correction Number
- Z-1546-2014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT LOW INRATIO2 INR RESULT IN COMPARISON TO THE TRAINING CENTER (TC) MONITOR AND ALTERNATE INR MONITOR. RESULTS ARE AS FOLLOWS: DATE: (B)(4) 2014, INRATIO2 INR: 3.3 (LOT K339923R) - 99008G1; TC MONITOR: 2.9 (LOT K332828) - 99008G1; TC MONITOR: 2.8 (LOT K332828) - 99007EU; ALTERNATE INR MONITOR: >8.0. TESTING PERFORMED ONE AFTER THE OTHER. REPORTEDLY, PATIENT WAS PROVIDED WITH A ALTERNATE INR MONITOR BY THE TRAINING CENTER TO MONITOR AT HOME. PATIENT DID NOT WANT TO GO TO THE ER. THERAPEUTIC RANGE FOR UNKNOWN FOR THIS PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 541482 | INTRATIO2 PT/INR PROFESSIONAL TEST STRIPS | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 99007EU | K332828 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INRATIO2 MONITOR: (B)(4)| COAGU CHEK XS| PHENPROCOUMON (MARCUMAR) |