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

Model Number 97000HS

Device Problem Incorrect, Inadequate or Imprecise Result or 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.

• Brand Name: TRIAGE CARDIAC PANEL
• Type of Device: TRIAGE 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 Key: 9857622
• MDR Text Key: 199227103
• Report Number: 3013982035-2020-00007
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2020
• Device Model Number: 97000HS
• Device Lot Number: T10774N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2019
• 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