TRIAGE PROFILER SOB PANEL 25T 97300EU

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2017-07-19 for TRIAGE PROFILER SOB PANEL 25T 97300EU manufactured by Alere San Diego, Inc..

Event Text Entries

[80473857] Investigation pending. This event is being reported as part number 97300eu is same/similar to 510 (k): k080269.
Patient Sequence No: 1, Text Type: N, H10


[80473858] The customer reported the following events occurring on one patient. The customer reported being concerned with the d-dimer results. On (b)(6) 2017, the patient arrived to the emergency department with chest pain. An initial draw was performed and both whole blood and plasma were collected in edta: (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2027969-2017-00120
MDR Report Key6725849
Report SourceCONSUMER,FOREIGN,HEALTH PROFE
Date Received2017-07-19
Date of Report2017-06-22
Date of Event2017-05-15
Date Mfgr Received2017-07-25
Date Added to Maude2017-07-19
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 ContactYA-LING KING
Manufacturer Street9975 SUMMERS RIDGE ROAD
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8588052084
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRIAGE PROFILER SOB PANEL 25T
Generic NameCARDIOPROFILER PANEL
Product CodeDAP
Date Received2017-07-19
Model Number97300EU
Lot NumberW62463B
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALERE SAN DIEGO, INC.
Manufacturer Address9975 SUMMERS RIDGE ROAD SAN DIEGO CA 92121 US 92121


Patients

Patient NumberTreatmentOutcomeDate
10 2017-07-19

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