TRIAGE PROFILER SOB PANEL 97300EUA

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 2019-05-07 for TRIAGE PROFILER SOB PANEL 97300EUA manufactured by Quidel Cardiovascular Inc..

Event Text Entries

[146361865] Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w64982n. No issues with d-dimer recovery were observed, lot performed properly. Manufacturing batch records for the lot were reviewed, lot met release specifications. Based on the information available, there is no indication of a product deficiency and no corrective action is required. Although this catalog number (97300eua) is not approved in the united states, this event is being reported as the device is same/similar to catalog number 98100, 510(k) number k042890.
Patient Sequence No: 1, Text Type: N, H10


[146361866] Event occurred in (b)(6). Customer reported discrepant low d-dimer results for 1 patient. Patient 2: normal triage d-dimer = 107 ng/ml. Ultrasound confirmed deep vein thrombosis. Customer's triage d-dimer cutoff- 400 ng/ml. Customer stated no treatment was withheld based on triage result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3013982035-2019-00010
MDR Report Key8588876
Report SourceCONSUMER,HEALTH PROFESSIONAL,
Date Received2019-05-07
Date of Report2019-05-07
Date of Event2019-04-05
Date Mfgr Received2019-04-08
Device Manufacturer Date2018-11-02
Date Added to Maude2019-05-07
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 FDA3
Event Location3
Manufacturer ContactJESSICA PERROTTE
Manufacturer Street9975 SUMMERS RIDGE ROAD
Manufacturer CitySAN DIEGO CA 92121
Manufacturer CountryUS
Manufacturer Postal92121
Manufacturer Phone8583020297
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTRIAGE PROFILER SOB PANEL
Generic NameTRIAGE PROFILER SOB PANEL
Product CodeDAP
Date Received2019-05-07
Model Number97300EUA
Lot NumberW64982N
Device Expiration Date2019-07-16
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2019-05-07

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