FDA Adverse Event
Malfunction
Summary report: N
HEMOCHRON RESPONSE COAGULATION SYSTEM
MDR report key: 1628964
·
Received March 10, 2010
Report
- Report Number
- 2248721-2010-00022
- Event Type
- Malfunction
- Date Received
- March 10, 2010
- Report Date
- March 9, 2010
- Manufacturer
- INTERNATIONAL TECHNIDYNE CORP.
- Product Code
- KQG
- PMA / PMN Number
- K983475
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE MANUFACTURER OBTAINING ADDITIONAL INFORMATION ABOUT EVENT FROM HEALTHCARE PROFESSIONAL.
Description of Event or Problem · 1
HEALTHCARE PROFESSIONAL REPORTS INCONSISTENT PATIENT REPORTS. INITIAL ACT RESULT OBTAINED OF 345 SECONDS. BOLUS OF HEPARIN ADMINISTERED (AMOUNT NOT REPORTED) FOLLOWED BY RETEST 15 MINUTES LATER. ACT TEST ABORTED WHEN DEVICE REACHED 745 SECONDS AND WAS STILL READING. SUBSEQUENT ACT RESULT OF 364 SECONDS WAS OBTAINED. A FOURTH TEST WAS CONDUCTED GENERATING AN ACT RESULT IN THE RANGE OF 700 SECONDS. THE NEXT TWO RETESTS WERE BOTH IN THE 300 SECONDS RANGE. HEALTHCARE PROFESSIONAL REPORTS A TARGET RANGE OF 450 SECONDS. NO REPORT OF ADVERSE EVENT, SERIOUS INJURY, OR INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOCHRON RESPONSE COAGULATION SYSTEM | RESPONSE INSTRUMENT | KQG | INTERNATIONAL TECHNIDYNE CORP. | HRS.110 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |