MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR INC. TRIAGE PROFILER SOB PANEL

Model Number 97300EU

Device Problem High Readings (2459)

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

Event Date 03/20/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing of retained devices of lot number t13694n.Retains of the complaint lot performed properly when tested with "normal" (apparently healthy) donors.Manufacturing batch records for lot t13694n 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 correction action is required.

Event Description

Event occurred in germany.Discrepant high triage sob d-dimer result compared to roche cobas 6000 d-dimer result for 1 patient.The patient was a 65 year old female.Symptoms: shortness of breath, tachycardia and a covid infection 2 weeks ago no final diagnosis.Reason for shortness of breath unknown.No treatment was administered based on the lab result having normal values.It was noted that inflammation markers crp and bks are elevated according the lab result.

• Brand Name: TRIAGE PROFILER SOB PANEL
• Type of Device: TRIAGE PROFILER SOB PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: chelsea lindgren ; 9975 summers ridge road; san diego, CA 92121 ; 8583020294
• MDR Report Key: 16820651
• MDR Text Key: 314083416
• Report Number: 3013982035-2023-00004
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K080269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2023
• Device Model Number: 97300EU
• Device Lot Number: T13694N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2022
• 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
• Treatment: TRIAGE METERPRO PN: (B)(6), SN: (B)(6).
• Patient Age: 65 YR
• Patient Sex: Female