TRIAGE CARDIAC TRIPLE MARKER PANEL 97000HS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2018-05-18 for TRIAGE CARDIAC TRIPLE MARKER PANEL 97000HS manufactured by Quidel Cardiovascular, Inc..

Event Text Entries

[108862681] Investigation pending. Malfunction mdr for lot w63722b report number: 3013982035-2018-00016.
Patient Sequence No: 1, Text Type: N, H10


[108862682] Customer stated they performed a patient correlation from two site locations. One patient yielded a ckmb of 3. 2ng/ml and myo of 96. 3ng/ml on lot w63542b at sister site. The sample was transported at room temperature and ran at customers site on lot w63722b. Results were ckmb 5. 3ng/ml and myo 140ng/ml. Customer could not provide additional information despite multiple attempts. A separate mdr will be filed for the results on lot w63722b.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3013982035-2018-00015
MDR Report Key7526053
Report SourceCONSUMER,HEALTH PROFESSIONAL,
Date Received2018-05-18
Date of Report2018-07-09
Date of Event2018-04-20
Date Mfgr Received2018-04-20
Device Manufacturer Date2017-09-12
Date Added to Maude2018-05-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJESSICA PERROTTE
Manufacturer Street9975 SUMMERS RIDGE ROAD
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8588053573
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRIAGE CARDIAC TRIPLE MARKER PANEL
Generic NameTRIAGE CARDIAC PANEL
Product CodeJHX
Date Received2018-05-18
Model Number97000HS
Lot NumberW63542B
Device Expiration Date2018-05-26
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerQUIDEL CARDIOVASCULAR, INC.
Manufacturer Address9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-18

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