TRIAGE PROFILER SOB PANEL 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 2018-04-16 for TRIAGE PROFILER SOB PANEL 97300EU manufactured by Quidel Cardiovascular, Inc..

Event Text Entries

[105760339] Investigation conclusion: the customer's complaint was not replicated with in-house testing of retain lot w63556b. No issues with tni recovery were observed. Manufacturing batch records for lot w63556b were reviewed and found that the lot met final release specifications. The customer could not provide patient diagnosis from the hospital specialized in cardiology. The only information available is patient is in good health condition. Based on the information available, there is no indication of a product deficiency and no corrective action is required. Although this catalog number (97300eu) is not approved in the united states, this event is being reported as the device is same/similar to catalog number 97300, 510(k) number k080269.
Patient Sequence No: 1, Text Type: N, H10


[105760340] A patient experienced respiratory distress and was tested for cardiac markers using the triage system. The triage system produced results of tni= <0. 05 ng/ml and bnp= 96 pg/ml. As the triage tni result was determined to be normal by the customer, the patient was taken to the emergency unit of a hospital instead of a hospital with a cardiology unit. The patient was tested in the emergency unit by another service an hour later and received results of tni= 0. 0792 ng/ml and bnp= 387 pg/ml (normal tni cutoff for this instrument= 0. 034 ng/ml). As this tni result was abnormal, the decision was made to transfer the patient to another hospital specialized in cardiology. The patient's diagnosis prior to transfer was heart failure and coronary distress. As of march 29, 2018, the patient is reported to be in good condition.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3013982035-2018-00008
MDR Report Key7434896
Report SourceCONSUMER,FOREIGN,HEALTH PROFE
Date Received2018-04-16
Date of Report2018-04-16
Date Mfgr Received2018-03-19
Device Manufacturer Date2017-10-16
Date Added to Maude2018-04-16
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 PROFILER SOB PANEL
Generic NameKIT, TRIAGE, SOB
Product CodeDAP
Date Received2018-04-16
Model Number97300EU
Lot NumberW63566B
Device Expiration Date2018-06-30
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 2018-04-16

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