FDA Adverse Event
Death
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 1550245
·
Received December 2, 2009
Report
- Report Number
- 2248721-2009-00603
- Event Type
- Death
- Date Received
- December 2, 2009
- Date of Event
- January 7, 2009
- Report Date
- December 2, 2009
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GJS
- PMA / PMN Number
- K961835
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MFR AWAITING PRODUCT RETURN FOR EVALUATION.
Description of Event or Problem · 1
HEALTHCARE PROVIDER REPORTS: PT'S DEATH ALLEGED TO BE ASSOCIATED WITH USE OF PROTIME SYSTEM. IN 2009, PROTIME SYSTEM INR RESULT 2.2 AND NO TREATMENT GIVEN OR WITHHELD. LATER THAT NIGHT, PT REPORTEDLY FELL AND HIT HEAD IN BATHROOM; EXPIRED LATER FROM CEREBRAL HEMORRHAGE. UNSPECIFIED LAB SYSTEM INR RESULT 4.08 THIRTEEN HOURS LATER. PT THERAPEUTIC RANGE REPORTED AS 2.2. NINE DAYS LATER, PROTIME SYSTEM INR RESULTS REPORTED ACCURATE ON ANOTHER PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTIME MICROCOAGULATION SYSTEM | PROTIME INSTRUMENT | GJS | INTERNATIONAL TECHNIDYNE CORP. | L11-01-01C | UNK - CUVETTE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Death |