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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR, INC. KIT, TRIAGE, CARDIAC TNI/CKMB

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QUIDEL CARDIOVASCULAR, INC. KIT, TRIAGE, CARDIAC TNI/CKMB Back to Search Results
Model Number 97022HS
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/09/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation conclusion: the customers complaint was not replicated during in-house testing of retain lot w63726rb with whole blood donors and in-house samples. Testing found no issues with product performance; no discordant ckmb results were observed. Manufacturing batch records for lot w63726rb were reviewed and found that the lot met final release specifications. No issues with ckmb recovery observed. The device was not returned for evaluation; however, patient sample was returned. Observed elevated ckmb results with the returned patient sample. Hama interference testing was inconclusive. The returned patient sample was observed to be severely hemolyzed. Although hama interference testing was inconclusive, additional sample specific factors/interference in the returned sample cannot be ruled out as the cause of the complaint. Based on the information available, there is no indication of a product deficiency and no corrective action is required. This event is related to mdr 3013982035-2018-00010.
 
Event Description
Customer reported discordant results for ckmb on triage compared to the beckman dxi analyzer. On (b)(6) 2018, patient presented to the urgent room for dizziness. Patient sample was run on an alternate triage lot number and resulted with an elevated ckmb result. Mdr 3013982035-2018-00010 captures this event. The patient sample was tested on the beckman dxi analyzer with a ckmb result of 3. 8 ng/ml. Sample was repeated on the dxi and yielded ckmb result of 4. 0 ng/ml. Customer provided the dxi cut-off of 6. 4 ng/ml. The patient sample was retested 3 days later on triage lot number w63726rb and yielded a ckmb result of 38. 9 ng/ml (similar to the original triage result). Customer stated the patient was admitted to the hospital for observation. Customer stated no treatment was given to the patient based on triage result and that the patient encountered no harm. There was no report of adverse health consequences due to the discordant ckmb result.
 
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Brand NameKIT, TRIAGE, CARDIAC TNI/CKMB
Type of DeviceKIT, TRIAGE, CARDIAC TNI/CKMB
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 Key7489128
MDR Text Key107999850
Report Number3013982035-2018-00011
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
Report Date 05/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/22/2018
Device Model Number97022HS
Device Lot NumberW63726RB
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 Received04/09/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/08/2018
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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