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

Model Number	97000HS
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Troubleshooting was performed with the customer.Technical support stressed the importance of testing patient samples within the 4-hour window for sample testing after collection per the product insert.Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w64711b.No issues with recovery were observed; lot performed properly.Manufacturing batch records for the lot were reviewed, lot met release specifications.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 discordant results for one patient sample drawn from patient on (b)(6) 2019 at 15:01.Sample tested on tosoh at 15:17 and yielded tni 0.65 and myo 50.9 (ckmb not tested on tosoh).Sample then tested on triage at 15:45 and yielded tni <0.05ng/ml, ckmb 2.4ng/ml and myo 136ng/ml.Sites normal ranges are: triage tni <0.05ng/ml tosoh <0.4 customer stated samples were stored refrigerated for 4 days and retested on both triage and tosoh (testing date of (b)(6) 2019).Triage tni <0.05ng/ml, myo 237 tosoh tni 1.16.Customer stated that the triage meter is backup to the tosoh instrument.Customer stated they did not believe the patient was having a heart attack as suggested by the tosoh instrument.Customer also called tosoh for troubleshooting.Customer could not provide additional patient information.

• Brand Name: TRIAGE CARDIAC PANEL
• Common Device Name: TRIAGE CARDIAC PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 8376175
• Report Number: 3013982035-2019-00003
• Device Sequence Number: 2198070
• Product Code: MMI
• UDI-Device Identifier: 00893038002197
• UDI-Public: (01)00893038002197(10)W64711B(17)190322(11)180708
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

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: 03/22/2019
• Device Model Number: 97000HS
• Device Lot Number: W64711B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2019
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRIAGE METERPRO PN 55070 SN: (B)(4).