FDA Adverse Event
Other
Summary report: N
HEMOCHRON ELITE MICROCOAGULATION SYSTEM
MDR report key: 2034700
·
Received March 18, 2011
Report
- Report Number
- 2248721-2011-00050
- Event Type
- Other
- Date Received
- March 18, 2011
- Date of Event
- February 28, 2011
- Report Date
- March 17, 2011
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- JPA
- PMA / PMN Number
- K050016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) (CUVETTE LOT #M0JPT095). METHOD: NO PRODUCT RETURNED. RESULT: CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. CONCLUSION: DEVICE NOT RETURNED. NO CONCLUSION CAN BE DRAWN. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.
Description of Event or Problem · 1
HEALTHCARE PROFESSIONAL REPORTS PATIENT WAS ADMITTED WITH LEG PAIN AND SWELLING. PT/INR ON (B)(6) 2011 WITH HEMOCHRON ELITE MICROCOAGULATION SYSTEM 2.9. A LAB DRAW WAS PERFORMED AND RESULTS WERE PT/INR 2.3. THE INSTRUMENT IS STILL IN USE. BOTH LIQUID QUALITY CONTROL AND ELECTRIC QUALITY CONTROL TESTS WERE ACCEPTABLE PRIOR TO THE PROCEDURE. THERAPEUTIC RANGE IS PT/INR 2.0-2.5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCHRON ELITE MICROCOAGULATION SYSTEM | JPA | INTERNATIONAL TECHNIDYNE CORP. | ELITE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization | METFORMIN| WARFARIN (COUMADIN)| COREG| DIAVAN| TYLENOL| EYE DROPS| LIPITOR| IMDUR| NORCO |