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

Model Number 98100

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing of retain device lot t11436n.Retains of the complaint lot were tested with a positive calibrator, no issues with d-dimer recovery were observed.Lot performed within specification.Manufacturing batch records for lot t11436n 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 Description

Customer reported poor d-dimer correlation between triage and star evolution.Correlation study was performed and initiated at the beginning of the pandemic in march.Customer provided their normal ranges for triage and star evolution: triage = 0-400ng/ml ddu, star evolution = 0-0.5 ug/ml feu.The following comparisons were conflicting given sites normal range from (b)(6) 2020 - (b)(6) 2020: triage 148ng/ml and 143ng/ml, star 0.51ug/ml, triage 253ng/ml and 351ng/ml, star 0.52ug/ml, triage <100ng/ml and <100ng/ml, star 0.67ug/ml, triage 263ng/ml and 253ng/ml, star 0.54ug/ml, triage 480ng/ml and 483ng/ml, star 0.48ug/ml, triage 181ng/ml, star 0.51ug/ml, triage 391ng/ml, star 0.58ug/ml, triage <100ng/ml, star 0.55ug/ml, triage 227ng/ml, star 0.53ug/ml, triage 355ng/ml, star 0.55ug/ml, triage 118ng/ml, star 0.54ug/ml, triage 170ng/ml, star 0.55ug/ml, triage 291ng/ml, star 0.59ug/ml, triage 278ng/ml, star 0.51ug/ml.Customer stated samples were only used for correlation purposes.

• Brand Name: TRIAGE D-DIMER PANEL
• Type of Device: TRIAGE D-DIMER PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego, ca
• Manufacturer Contact: jessica perrotte ; 9975 summers ridge road; san diego, ca ; 3020297
• MDR Report Key: 10440299
• MDR Text Key: 204547338
• Report Number: 3013982035-2020-00031
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2021
• Device Model Number: 98100
• Device Lot Number: T11436N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1