MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR INC. TRIAGE CARDIAC HS PANEL; 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	09/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: the customers complaint was not replicated with in-house testing of retain lot t10202b.No issues with tni recovery were observed.Manufacturing batch records for lot t10202b 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.
Event or Problem Description
Patient, a (b)(6) boy, presented to the er with chest pain that woke him up twice in the night and a headache from hitting his head when rough housing with his brother.Came to er, (b)(6) 2019 at 12:25 a.M.Draw times and test times unavailable for the siemens dimension, but testing would have been performed 15 to 30 minutes prior to the triage since triage is the backup to the siemens dimension siemens dimension exl troponin: lithium heparin, plasma; result=0.204, sst, serum, result=0.216, lithium heparin, plasma; result=0.221.Triage tests lavender top (edta) wb sample triage meter, 2 draws, result= <0.05 x2 at 1:45 a.M.And 2:22 a.M.Myo=34.2 and 42.8; ck-mb=2.4 and 3.1.Triage meter range tni: normal is <0.05.Siemens dimension reference range: 0.000-0.050.Customer stated no treatments were withheld based on triage results.Patient was transferred to (b)(6) hospital.Although requested, patient diagnosis is not available.Treating doctor at customer site feels that the child has acute myocarditis.Customer stated triage was passing controls without any issues.

• Brand Name: TRIAGE CARDIAC HS PANEL
• Common Device Name: TRIAGE CARDIAC PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 9211001
• Report Number: 3013982035-2019-00025
• Device Sequence Number: 2950589
• Product Code: MMI
• UDI-Device Identifier: 00893038002197
• UDI-Public: (01)00893038002197(10)T10202B(17)191021(11)190207
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 09/20/2019

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: 10/21/2019
• Device Model Number: 97000HS
• Device Catalogue Number: 97000HS
• Device Lot Number: T10202B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR