FDA Adverse Event
Injury
Summary report: N
INRATIO PT/INR TEST STRIPS
MDR report key: 3862849
·
Received May 22, 2014
Report
- Report Number
- 2027969-2014-00479
- Event Type
- Injury
- Date Received
- May 22, 2014
- Date of Event
- April 27, 2014
- Report Date
- April 28, 2014
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Removal / Correction Number
- Z-1564-2014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGED DISCREPANT LOW INRATIO INR RESULT IN COMPARISON TO THE LABORATORY INR RESULT. ON (B)(6) 2014, LABORATORY INR WAS 13.0 AND COUMADIN WAS HELD. (B)(6) 2014, LABORATORY INR WAS 13.1 AND THE PATIENT WAS SEEN IN THE EMERGENCY ROOM AND ADMINISTERED VITAMIN K. ON (B)(6) 2014, INRATIO INR WAS 1.4 AND THE LABORATORY INR WAS 11.0; COUMADIN WAS HELD. THE TIME BETWEEN TESTING WAS WITHIN FIVE (5) MINUTES. THE SAME DAY, THE PATIENT WAS HOSPITALIZED DUE TO LETHARGY AND GENERAL DEGENERATION OF CONDITION. AS OF (B)(6) 2014, THE PATIENT REMAINED HOSPITALIZED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306917 | INRATIO PT/INR TEST STRIPS | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100139 | 340804 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | BACTRIM| ASPIRIN 81MG DAILY| VITAMIN D3| CRESTOR| DIAGOXIN| DILTIAZEM HYDROCHLORIDE| SENNA| TRAMADOL| CALCIUM| INRATIO MONITOR, SN: (B)(4).| COUMADIN| TYLENOL 325MG 3X/WEEK| CYMBALTA| CIPRO |