FDA Adverse Event
Malfunction
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 1733980
·
Received June 8, 2010
Report
- Report Number
- 2248721-2010-00092
- Event Type
- Malfunction
- Date Received
- June 8, 2010
- Date of Event
- May 10, 2010
- Report Date
- June 8, 2010
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GKP
- PMA / PMN Number
- K951072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MFR AWAITING PRODUCT RETURN FOR FURTHER EVALUATION.
Description of Event or Problem · 1
HEALTHCARE PROVIDER REPORTS: PROTIME SYSTEM INR RESULTS LOWER THAN REF LAB. ON (B)(6) 2010, PT TESTED AND NO CLOT WAS DETECTED. ON (B)(6) 2010, PROTIME INR 1.5 RETEST WAS 2.0. PT'S INR THERAPEUTIC RANGE: 2.0-3.0. PROVIDER REPORTED: "UNABLE TO ASCERTAIN IF LOW MOLECULAR WEIGHT HEPARIN SHOULD BE STOPPED OR VITAMIN K BE GIVEN. NURSE NOTED THE PT WAS "VERY SICK" AND DISCHARGED TO GO HOME. NO HOSPITALIZATION. PT'S INR LEVEL WAS STABILIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTIME MICROCOAGULATION SYSTEM | PROTIME INSTRUMENT | GKP | INTERNATIONAL TECHNIDYNE CORP. | PROPH110 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LMWH| APIXABAN| WARFARIN |