FDA Adverse Event
Malfunction
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 2516706
·
Received March 30, 2012
Report
- Report Number
- 2248721-2012-00033
- Event Type
- Malfunction
- Date Received
- March 30, 2012
- Date of Event
- March 5, 2012
- Report Date
- March 5, 2012
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- GJS
- PMA / PMN Number
- K961835
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CUVETTE LOT # NOT PROVIDED. METHOD: ACTUAL DEVICE EVALUATED. PROCESS EVALUATION PERFORMED. NO RELATED NCMRS, COMPLAINT TRENDS, OR CAPA IDENTIFIED. RESULT: NO FAILURE DETECTED. CONCLUSION: UNABLE TO CONFIRM COMPLAINT. PER THE LIMITATIONS IN THE PACKAGE INSERT, RESULTS MAY BE AFFECTED IN PATIENTS RECEIVING HEPARIN OR HAVE ABNORMAL RESPONSE TO HEPARIN. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3400A.
Description of Event or Problem · 1
PT SELF-TESTER REPORTS RESULTS HIGHER THAN EXPECTED WITH THE PROTIME MICROCOAGULATION SYSTEM. PROTIME GENERATED 9.1 INR AND ON THE SAME DAY HOSPITAL CLINIC GENERATED 2.5 INR. PT TOOK LOVENOX (LOW-MOLECULAR WEIGHT HEPARIN, LMWH) THE PREVIOUS NIGHT. PT'S THERAPEUTIC RANGE: 2.5-3.5. NO ADVERSE EVENT(S) REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTIME MICROCOAGULATION SYSTEM | GJS | INTERNATIONAL TECHNIDYNE CORP. | PROTIMEPST |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |