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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR INC. TRIAGE CARDIAC TRIPLE MARKER PANEL TRIAGE CARDIAC PANEL

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QUIDEL CARDIOVASCULAR INC. TRIAGE CARDIAC TRIPLE MARKER PANEL TRIAGE CARDIAC PANEL Back to Search Results
Model Number 97000HS
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Investigation pending. Malfunction mdr for lot w63243b report number: 3013982035-2018-00004.
 
Event Description
The customer reported observing a variance for myoglobin during a lot to lot comparison with two different triage cardiac lot numbers. Patient results: triage cardiac lot w63243b, myo
=
90. 1, triage cardiac lot w63316b, myo
=
118. Myoglobin reference range: 0-106 ng/ml. Patient was not treated based on the triage results.
 
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Brand NameTRIAGE CARDIAC TRIPLE MARKER PANEL
Type of DeviceTRIAGE CARDIAC PANEL
Manufacturer (Section D)
QUIDEL CARDIOVASCULAR INC.
9975 summers ridge road
san diego CA 92121
Manufacturer Contact
jessica perrotte
9975 summers ridge road
san diego, CA 92121
8588053573
MDR Report Key7250241
MDR Text Key99316517
Report Number3013982035-2018-00005
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030286
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/29/2018
Device Model Number97000HS
Device Lot NumberW63316B
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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