HEMOCHRON RESPONSE COAGULATION SYSTEM HRS. 110

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-09-13 for HEMOCHRON RESPONSE COAGULATION SYSTEM HRS. 110 manufactured by International Technidyne Corp..

Event Text Entries

[1474719] Healthcare provider reports problems with the hemochron response instrument giving unexpectedly high results during a cath lab procedure. The tubes were pulled at times greater than 800: 7:35am, pulled at 828, 7:50am, pulled at 1026. No adverse event reported.
Patient Sequence No: 1, Text Type: D, B5


[8786845] (b)(4). Manufacturer awaiting additional information for further complaint evaluation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2248721-2010-00129
MDR Report Key1836753
Report Source05
Date Received2010-09-13
Date of Report2010-09-13
Date of Event2010-05-15
Date Mfgr Received2010-08-20
Date Added to Maude2011-01-26
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 NameHEMOCHRON RESPONSE COAGULATION ANALYZER
Product CodeKQG
Date Received2010-09-13
Model NumberHRS. 110
Catalog NumberHRS. 110
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINTERNATIONAL TECHNIDYNE CORP.
Manufacturer AddressEDISON NJ 08820 US 08820


Patients

Patient NumberTreatmentOutcomeDate
10 2010-09-13

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