ULTEGRA RPFA-TRAP 85013 INSTR.

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-10-26 for ULTEGRA RPFA-TRAP 85013 INSTR. manufactured by Accumetrics.

Event Text Entries

[168544] A blood sample was drawn from a pt to obtain a baseline (pre-drug) platelet function test result using the ultegra rpfa-trap. A result of 56 pau was obtained. This value is significantly lower than the baseline reference range cited in the device package insert (125-330 pau). Ten minutes after administration of eptifibatide another blood sample was drawn, and a post bolus test result of 17 pau was obtained. A second administration (bolus) of eptifibatide was given. Another blood sample was drawn ten minutes after the second bolus, and a result of 18 pau was obtained.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2031760-2000-00012
MDR Report Key302738
Report Source05,06
Date Received2000-10-26
Date of Report2000-10-26
Date of Event2000-09-28
Date Mfgr Received2000-09-28
Device Manufacturer Date2000-07-01
Date Added to Maude2000-11-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactRHONDA MOE
Manufacturer Street3985 SORRENTO VALLEY BLVD
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8586431600
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameULTEGRA RPFA-TRAP
Generic NamePLATELET FUNCTION ASSAY
Product CodeJOZ
Date Received2000-10-26
Model NumberNA
Catalog Number85013 INSTR.
Lot NumberW12201
ID Number85011 CARTRIDGE
Device Expiration Date2001-02-17
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key293021
ManufacturerACCUMETRICS
Manufacturer Address3985 SORRENTO VALLEY BLVD SAN DIEGO CA 92121 US
Baseline Brand NameULTEGRA RPFA-TRAP
Baseline Generic NamePLATELET FUNCTION ASSAY
Baseline Catalog No85013 INSTR.
Baseline ID85011 CARTRIDGE
Baseline Device FamilyNA
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]6
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK992531
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2000-10-26

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