FDA Adverse Event
Malfunction
Summary report: N
INRATIO
MDR report key: 3023017
·
Received March 21, 2013
Report
- Report Number
- 2027969-2013-00239
- Event Type
- Malfunction
- Date Received
- March 21, 2013
- Date of Event
- March 13, 2013
- Report Date
- March 21, 2013
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- GJS
- PMA / PMN Number
- K092987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION PENDING.
Description of Event or Problem · 1
"CALLER ALLEGED DISCREPANT RESULTS COMPARED WITH THE LAB. RESULTS AS FOLLOWS:" DATE: (B)(6) 2013, LAB: 1.7; DATE: (B)(6) 2013, LAB: 1.5; DATE: (B)(6) 2013, INRATIO: 3.0, LAB: 1.7. PATIENT ADMITTED TO HOSPITAL FOR HEAVY CHEST PAIN; HAD LOW POTASSIUM; PLACED ON HEPARIN DRIP DURING HOSPITAL STAY ((B)(6)). BOTH SAMPLES TAKEN FROM PATIENT WITHIN 2 HOURS ON (B)(6) 2013. THERAPEUTIC RANGE: 2.5 - 3.5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 117495 | INRATIO | PROTHROMBIN TIME TEST | GJS | ALERE SAN DIEGO, INC. | 100071 | 275252 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |