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U.S. Department of Health and Human Services

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

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QUIDEL CARDIOVASCULAR INC. TRIAGE CARDIAC PANEL Back to Search Results
Model Number 97000HS
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/18/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation conclusion: triage labeling does not make any claims to correlate to the stratus method for ckmb. Various ckmb assays are not standardized and therefore may have a difference in values depending on the assay used. The customers complaint was not replicated with in-house testing of retain lot t10774n. No issues with ckmb recovery were observed. Manufacturing batch records for lot t10774n were reviewed and found that the lot met final release specifications. The root cause could not be determined. Based on the information available, there is no indication of a product deficiency and no corrective action is required.
 
Event Description
Customer reported poor correlation for ckmb between triage platform and stratus cs. Customer stated they have not used the triage for any patient reporting. The correlations were done anonymously, therefore no patient details or information can be obtained. Triage ckmb: 3. 6 compared to stratus ckmb: 8. 4. Triage ckmb: 4. 6 compared to stratus ckmb: 2. 8. Sites ckmb reference range for the platforms: triage <4. 3. Stratus 0. 0-5. 0.
 
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Brand NameTRIAGE CARDIAC PANEL
Type of DeviceTRIAGE CARDIAC PANEL
Manufacturer (Section D)
QUIDEL CARDIOVASCULAR INC.
9975 summers ridge road
san diego, ca
Manufacturer Contact
jessica perrotte
9975 summers ridge road
san diego, ca 
3020297
MDR Report Key9857622
MDR Text Key199227103
Report Number3013982035-2020-00007
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/16/2020
Device Model Number97000HS
Device Lot NumberT10774N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/02/2019
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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