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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 02/22/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation conclusion: the customer's complaint was not replicated with in-house testing of retain lot w63532rb.No issues with ckmb recovery were observed.Manufacturing batch records for lot w63532rb were reviewed and found that the lot met final release specifications.The customer returned the two patient draws associated with the reported discrepancy.Testing of the patient sample returns on retains of device lot w63532rb did not replicate customers complaints.All ckmb results for the patient draws were below customers cut-off of 4.3ng/ml.Unable to replicate or determine root cause of customers reported discrepant high ckmb result.Based on the information available, there is no indication of a product deficiency and no corrective action is required.
 
Event Description
Customer reported imprecision results for ckmb on triage lot number w63532rb for a patient.On (b)(6) 2018, patient was tested and the following results were received: 7:30am: sample 1, resulted ckmb 5.3ng/ml; 10:30am: sample 2, redraw (new device) resulted ckmb 3.0ng/ml customers ckmb cut-off: 4.3ng/ml.Patient was administered heparin bolus followed by a heparin drip prior to the 10:30am draw and result.Patient outcome: flare up of chf with no mi.Patient is doing well in skilled bed at this time.Customer provided additional information on 2/27/2018 of their repeat testing for the two patient draws: repeat testing: sample 1 (same tube of 7:30am draw) using plasma resulted ckmb=4.4.Sample 2 (same tube of 10:30am draw) using plasma resulted ckmb=3.2, (3) sample 2 (same tube of 10:30am draw) using wb resulted ckmb=2.7.There is no information to suggest the triage ckmb result of 5.3ng/ml altered patient treatment.
 
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Brand Name
KIT, TRIAGE, CARDIAC TNI/CKMB
Type of Device
KIT, 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 Key7367239
MDR Text Key103792083
Report Number3013982035-2018-00007
Device Sequence Number1
Product Code JHX
UDI-Device Identifier00899722002795
UDI-Public(01)00899722002795(10)W63532RB(17)180506(11)170822
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 Health Professional
Type of Report Initial
Report Date 03/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/06/2018
Device Model Number97022HS
Device Lot NumberW63532RB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/22/2018
Initial Date FDA Received03/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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