FDA Adverse Event
Injury
Summary report: N
COUMATRAK PROTIME TEST SYSTEM
MDR report key: 31448
·
Received January 11, 1995
Report
- Report Number
- 1054435-1994-00007
- Event Type
- Injury
- Date Received
- January 11, 1995
- Report Date
- January 11, 1995
- Manufacturer
- BOEHRINGER MANNHEIM CORP.
- Product Code
- GJS
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NE, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
A NURSE REPORTED THAT A PT, WHO WAS TAKING COUMADIN FOR A CLOT IN THE LEG, HAD A PT (PROTHROMBIN TIME) OF 14 SECONDS USING A TEST SYSTEM IN THE PHYSICIAN'S OFFICE. AS A RESULT, THE PHYSICIAN INCREASED THE PT'S COUMADIN DOSAGE. THE PT WAS SUBSEQUENTLY ADMITTED TO THE HOSP WITH A BLOODY NOSE. ON ADMISSION, PT WAS 37 SECONDS. THE NURSE STATED THAT THE ELECTRONIC CONTROLS WERE INTACT. RESULTS ON WHOLE BLOOD CONTROLS AND DESCRIPTION OF TECHNIQUE WERE NOT PROVIDED. THE MONITOR WAS RETURNED TO THE MFR FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COUMATRAK PROTIME TEST SYSTEM | IN VITRO HEMATOLOGY DEVICE | GJS | BOEHRINGER MANNHEIM CORP. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |