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	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation pending.
Event or Problem Description
Customer reported a discordant d-dimer result with 1 patient sample while running a whole blood to plasma correlation study.Triage d-dimer: whole blood: 215ng/ml; plasma: 448ng/ml.Patient sample resulted on stago with a d-dimer of 0.62mg/ml feu.Customer stated stago results would have been what was used by the physician.Facility triage d-dimer cut-off = 400ng/ml, facility stago d-dimer cut-off = 0.50mg/ml feu.Customer could not provide diagnosis information for the patient but stated the patient "presented with dizziness, nausea and pleurisy, anxiety and depression".
Additional Manufacturer Narrative
Investigation conclusion: manufacturer tested whole blood and plasma samples from unique donors on retains of triage d-dimer device lot w64241b; d-dimer results from both sample types provided the same clinical outcome.Manufacturing batch records for the lot were reviewed, lot met release specifications.The triage d-dimer test is to be used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.Each laboratory should establish a reference range that is representative of the patient population to be evaluated.Based on the information available, there is no corrective action 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: 8162942
• Report Number: 3013982035-2018-00032
• Device Sequence Number: 19382804
• Product Code: GHH
• UDI-Device Identifier: 00893038002326
• UDI-Public: (01)00893038002326(10)W64241B(17)190317(11)180603
• 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
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 03/17/2019
• Device Model Number: 98100
• Device Catalogue Number: 98100
• Device Lot Number: W64241B
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 04/01/2019
• 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)