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

Model Number 98100

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2021

Event Type  malfunction  

Event Description

Caller questioning why results are flagged high on the aclh 500 but not on the triage meter.On (b)(6) 2021: aclh 500 874 feu vs.Triage meter, 504 ddu.Caller stated both testing methods were accidentally requested.On (b)(6) 2021: aclh 500, 878 feu vs.Triage meter, 561 ddu.Site cutoffs: 500 feu for aclh 500; 600 ng/ml for triage meter.Caller stated there were no issues with triage controls or cal vers, results within 1sd.No further information available as customer is not responding.Unsure what treatment if any was provided or withheld.

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing of retain device lot t11855n.Retains of the complaint lot were tested with a positive calibrator, no issues with d-dimer recovery were observed.The lot performed properly.Manufacturing batch records for lot t11855rn 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.

• 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 92121
• MDR Report Key: 11449107
• MDR Text Key: 280450245
• Report Number: 3013982035-2021-00004
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• PMA/PMN Number: K042890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2021
• Device Model Number: 98100
• Device Lot Number: T11855N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRIAGE METERPRO (PN: 55070) SN: (B)(4)
• Patient Age: 64 YR