FDA Adverse Event
Malfunction
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 2932267
·
Received January 22, 2013
Report
- Report Number
- 2248721-2013-00005
- Event Type
- Malfunction
- Date Received
- January 22, 2013
- Date of Event
- December 1, 2012
- Report Date
- December 27, 2012
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP
- Product Code
- GJS
- PMA / PMN Number
- K961835
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CUVETTE LOT# WAS NOT PROVIDED BY THE CUSTOMER. METHOD: ACTUAL DEVICE NOT EVALUATED. PROCESS EVALUATION PERFORMED. NO NCMRS IDENTIFIED FOR THIS INSTRUMENT.
Description of Event or Problem · 1
PT-SELF TESTER REPORTS INCONSISTENT RESULTS WITH THE PROTIME MICROCOAGULATION SYSTEM. PROTIME GENERATED 3.0 INR. PT SELF-TESTER IMMEDIATELY RETESTED AND PROTIME GENERATED 0.8 INR. ADDITIONAL RETESTS GENERATED AN ON-BOARD QC OUT OF RANGE ERROR AND BATTERY ERROR. PT'S THERAPEUTIC RANGE: 1.0-2.0 INR. NO ADVERSE EVENT(S) REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31505 | PROTIME MICROCOAGULATION SYSTEM | GJS | INTERNATIONAL TECHNIDYNE CORP | PROTIMEPST |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |