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

Model Number	97022HS
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.

• Brand Name: KIT, TRIAGE, CARDIAC TNI/CKMB
• Common Device Name: KIT, TRIAGE, CARDIAC TNI/CKMB
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 7367239
• Report Number: 3013982035-2018-00007
• Device Sequence Number: 1718804
• Product Code: JHX
• UDI-Device Identifier: 00899722002795
• UDI-Public: (01)00899722002795(10)W63532RB(17)180506(11)170822
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K030286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2018
• Device Model Number: 97022HS
• Device Lot Number: W63532RB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1