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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR, INC. TRIAGE CARDIAC PANEL KIT TRIAGE CARDAIC PANEL

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QUIDEL CARDIOVASCULAR, INC. TRIAGE CARDIAC PANEL KIT TRIAGE CARDAIC PANEL Back to Search Results
Model Number 97000HSEU
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/19/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation conclusion: the customer's complaint was not replicated with in-house testing of retain lot w63541rb. No issues with ckmb recovery were observed. Manufacturing batch records for lot w63541rb 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. Although this catalog number (97000hseu) is not approved in the united states, this event is being reported as the device is same/similar to catalog number 97000hs, 510(k) number k030286.
 
Event Description
Customer alleged their latest box of triage cardiac lot w63451rb was giving elevated results for ckmb while myo and tni were less than the reference value. The customer provided results of 5. 8ng/ml, 5. 9ng/ml, 5. 6ng/ml, 7. 5ng/ml and 4. 5ng/ml for ckmb. The customer could only provide data comparison for the result of 4. 5ng/ml. The sample when tested on an alternate triage product lot number yielded a ckmb of 3. 8ng/ml. The customer stated they do not have concerns with the alternate triage product lot. The customer stated the patients were not correlated with a mi. No additional information provided.
 
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Brand NameTRIAGE CARDIAC PANEL KIT
Type of DeviceTRIAGE CARDAIC 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 Key7439653
MDR Text Key105898996
Report Number3013982035-2018-00009
Device Sequence Number1
Product Code JHX
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
K030286
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation
Type of Report Initial
Report Date 04/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/19/2018
Device Model Number97000HSEU
Device Lot NumberW63541RB
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 Received03/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/05/2017
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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