HEMOCHRON RESPONSE COAGULATION SYSTEM HRS. RF HRS. FR / HRFTCA510

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-03-10 for HEMOCHRON RESPONSE COAGULATION SYSTEM HRS. RF HRS. FR / HRFTCA510 manufactured by International Technidyne Corp..

Event Text Entries

[1332512] Healthcare professional reports inconsistent patient results. Hemochron response system consistently giving act results greater than 1500 seconds, on multiple non- heparinized patients. Healthcare professional did not indicate number of patients involved. No report of adverse event, serious injury, or intervention reported. This event occurred in a foreign country.
Patient Sequence No: 1, Text Type: D, B5


[8448140] (b)(4). Manufacturer's evaluation currently in process.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2248721-2010-00023
MDR Report Key1628963
Report Source08
Date Received2010-03-10
Date of Report2010-03-09
Date Mfgr Received2010-02-09
Date Added to Maude2010-08-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLAWRENCE PICCIANO
Manufacturer Street8 OLSEN AVE.
Manufacturer CityEDISON NJ 08820
Manufacturer CountryUS
Manufacturer Postal08820
Manufacturer Phone7325485700
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHEMOCHRON RESPONSE COAGULATION SYSTEM
Generic NameRESPONSE INST / ACT TUBE ASSAY
Product CodeKQG
Date Received2010-03-10
Returned To Mfg2010-03-04
Model NumberHRS. RF
Catalog NumberHRS. FR / HRFTCA510
Lot NumberC9FTE061A
Device Expiration Date2012-03-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTERNATIONAL TECHNIDYNE CORP.
Manufacturer AddressEDISON NJ 08820 US 08820


Patients

Patient NumberTreatmentOutcomeDate
10 2010-03-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.