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

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.

• Brand Name: TRIAGE CARDIAC PANEL KIT
• Type of Device: TRIAGE 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 Key: 7439653
• MDR Text Key: 105898996
• Report Number: 3013982035-2018-00009
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K030286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/18/2018

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 Date: 05/19/2018
• Device Model Number: 97000HSEU
• Device Lot Number: W63541RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2017
• 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