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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 conclusion: the customers complaint was not replicated with in-house testing of retain lot w63243b. No issues with myo recovery observed. Manufacturing batch records for lot w63243b were reviewed and found that the lot met final release specifications. Based on the information available, there is no indication of a product deficiency and no corrective action is required.
 
Manufacturer Narrative
Investigation pending. Malfunction mdr for lot w63316b report number: 3013982035-2018-00005.
 
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
MDR Report Key7250167
MDR Text Key283500684
Report Number3013982035-2018-00004
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
PMA/PMN Number
K030286
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
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 Date01/15/2018
Device Model Number97000HS
Device Lot NumberW63243B
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/10/2018
Is This a Reprocessed and Reused Single-Use Device? No

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