FDA Adverse Event
Malfunction
Summary report: N
INRATIO2 PT/INR PROFESSIONAL TEST STRIP
MDR report key: 3874383
·
Received April 21, 2014
Report
- Report Number
- 2027969-2014-00362
- Event Type
- Malfunction
- Date Received
- April 21, 2014
- Date of Event
- April 2, 2014
- Report Date
- April 2, 2014
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K110212
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT LOW INRATIO2 INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. RESULTS ARE AS FOLLOWS: DATE: (B)(6) 2014; INRATIO2 INR: 5.2; LABORATORY INR: 2.1; THERAPEUTIC RANGE: 2.0 - 3.0. THE EXACT TIME BETWEEN TESTING IS UNKNOWN, HOWEVER, BOTH TESTS PERFORMED ON THE SAME DAY. REPORTEDLY, MULTIPLE DROPS OF BLOOD WAS ADDED TO THE SAMPLE STRIP. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THOUGH REQUESTED, THE CUSTOMER WAS UNWILLING TO PROVIDE SPECIFIC PATIENT DATA. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241015 | INRATIO2 PT/INR PROFESSIONAL TEST STRIP | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 99008G2 | 335553 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | INRATIO MONITOR, SN UNK |