FDA Adverse Event
Malfunction
Summary report: N
PROTIME MICROCOAGULATION SYSTEM
MDR report key: 2062402
·
Received March 18, 2011
Report
- Report Number
- 2248721-2011-00041
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 6, 2011
- Report Date
- March 7, 2011
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORPORATION
- Product Code
- GKP
- PMA / PMN Number
- K951072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). METHOD: DEVICE HAS BEEN REQUESTED. NO PRODUCT RETURNED. RESULT: CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. CONCLUSION: NO CONCLUSION CAN BE DRAWN. ITC HAS REQUESTED ALL DATA REQUIRED FOR FORM 3500A.
Description of Event or Problem · 1
HEALTHCARE PROFESSIONAL REPORTS DISCREPANT RESULTS ON PROTIME MICROCOAGULATION SYSTEM. ON (B)(6) 2011, CUSTOMER REPORTED PT/INR 2.3 ON PROTIME. ON (B)(6) 2011, PT WAS SENT TO HOSPITAL FOR STOMACH PAIN. HOSPITAL LAB INR WAS 4.0. REPORTER STATED PT HAD OTHER UNSPECIFIED PROBLEMS AND WAS GIVEN AN UNK DOSAGE OF VITAMIN K.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTIME MICROCOAGULATION SYSTEM | GKP | INTERNATIONAL TECHNIDYNE CORPORATION | PROTIMEPRO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |