MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR INC. TRIAGE D-DIMER PANEL

Model Number	98100
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer called in precision issue with the triage d-dimer panel with one patient.On (b)(6) 2021 patient came into facility with clotting issues.Patient was being treated for the clotting and rehydrated based on symptoms prior to physicians receiving the initial d-dimer result.Initial d-dimer result on triage >5000ng/ml.An hour later a new draw was collected and d-dimer result on triage <100ng/ml.Site cut-off for d-dimer on triage >600ng/ml.No confirmatory testing performed.Patient flown to alternate hospital for care, no additional information on patient available.Customer thinks she recalls the first sample having some clumping, possibly cold agglutination, or aggregation; however, not sure.An update provided by the customer, stated the patient was treated with heparin and nurse may have drawn the sample.Customer not sure if the draw was taken from the arm receiving heparin.Customer stated it might have been a sample draw error, but not sure.
Additional Manufacturer Narrative
Investigation conclusion: customer mentioned potential issues with both samples collected from the patient; possible cold agglutinin and draw error.These issues can affect device performance and recovery, technical support provided customer information from the package insert.The customers complaint was not replicated during in-house testing of retain device lot t12158n.Retains of the complaint when tested with an in-house calibrator performed proprerly, no precision issues observed.Manufacturing batch records for lot t12158n were reviewed and found that the lot met final release specifications.Unable to determine root cause of complaint.Based on the information available, there is no indication of a product deficiency and no correction action is required.

• Brand Name: TRIAGE D-DIMER PANEL
• Common Device Name: TRIAGE D-DIMER PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 12250335
• Report Number: 3013982035-2021-00016
• Device Sequence Number: 17237441
• Product Code: GHH
• UDI-Device Identifier: 30014613338000
• UDI-Public: (01)30014613338000(10)T12158N(17)220126(11)210412
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K042890
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

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: 01/26/2022
• Device Model Number: 98100
• Device Catalogue Number: 98100
• Device Lot Number: T12158N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/29/2021
• 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 METER PN: 55070, SN: (B)(4)