FDA Adverse Event
Malfunction
Summary report: N
HEMOCHRON JR SIGNATURE SYSTEM
MDR report key: 2057974
·
Received March 9, 2011
Report
- Report Number
- 2248721-2011-00033
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Report Date
- February 10, 2011
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- JPA
- PMA / PMN Number
- K940401
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MANUFACTURER/EVALUATION/INVESTIGATION CURRENTLY IN PROCESS. ACTUAL DEVICE INVOLVED IN COMPLAINT WAS EVALUATED. CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. NO CONCLUSION CAN BE DRAWN. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.
Description of Event or Problem · 1
PATIENT 2 OF 2. HEALTHCARE PROFESSIONAL REPORTS HEMOCHRON JR SIGNATURE SYSTEM DISCREPANCY SINCE SWITCHING CUVETTE LOT. PT/INR 6.2, LAB PT/INR 2.6. PATIENT TREATMENT WAS BASED ON THE LAB PT/INR. THE PATIENT'S THERAPEUTIC RANGE IS 2.0-3.0. PATIENT IS ON ANTICOAGULATION REGIMEN OF BOTH COUMADIN AND LOW MOLECULAR WEIGHT HEPARIN. ALL LIQUID QUALITY CONTROL TESTS HAVE BEEN ACCEPTABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCHRON JR SIGNATURE SYSTEM | JPA | INTERNATIONAL TECHNIDYNE CORP. | HEM JR-CUVET FG | H0JPT081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | COUMADIN| LOVENOX |