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

Model Number 97022HS

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customers complaint was not replicated during in-house testing of retain lot w63552rb 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 w63552rb 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 3013982035-2018-00011.

Event Description

Customer reported discordant results for ckmb on triage compared to the beckman dxi analyzer.Patient presented to the urgent room for dizziness.Patient sample was run on triage lot number w63552rb and resulted with ckmb of 38.7 ng/ml.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 on an alternate triage device lot 3 days later and the result was similar to the original triage result.Mdr 3013982035-2018-00011 captures this event.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.

• 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 Key: 7489084
• MDR Text Key: 107998680
• Report Number: 3013982035-2018-00010
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2018
• Device Model Number: 97022HS
• Device Lot Number: W63552RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1