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 Consequences Or Impact To Patient (2199)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w64237b.No issues with d-dimer 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
The customer reported variability between results produced on the triage d-dimer system.Customer stated on (b)(6) 2018 a patient presented to the clinic with "pain in lower left extremity (clot)".Patient sample was tested on triage and produced d-dimer results of 202ng/ml, 163ng/ml, and 571ng/ml.The specific time of testing was not provided but customer stated testing was all done on the same day.Clinics reference range for triage d-dimer is <400ng/ml.Customer stated no other lab tests were performed and customer did not know patient diagnosis/outcome, treatment or medical history.

• 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: 7853057
• Report Number: 3013982035-2018-00025
• Device Sequence Number: 16640907
• Product Code: GHH
• UDI-Device Identifier: 00893038002326
• UDI-Public: (01)00893038002326(10)W64237B(17)190211(11)180428
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K042890
• 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): 09/06/2018

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: 02/11/2019
• Device Model Number: 98100
• Device Lot Number: W64237B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 09/06/2018
• 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 KIT, PN: 55070, SN: (B)(4)
• Patient Age: 68 YR