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

Model Number 97300EU

Device Problem High Test Results (2457)

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing of retain device lot t11680n.Retains of the complaint lot performed properly when tested with "normal" (apparently healthy) donors.Manufacturing batch records for lot t11680n 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.Although this catalog number (97300eu) is not approved in the united states, the event is being reported as the device is same/similar to catalog number 97300, 510(k) number k080269.

Event Description

Customer reported a patient after pulmonary embolism was tested for d-dimer on triage and resulted abnormal at 1250ng/ml.Lab result with sample taken at the same time as triage result was normal at 560ug/l.Cutoff for triage: 400ng/ml, cutoff for lab analyzer: 590ug/l.The timing between pulmonary embolism diagnosis and triage testing event was not provided.

• 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: jessica perrotte ; 9975 summers ridge road; san diego, CA 92121 ; 8583020297
• MDR Report Key: 11416728
• MDR Text Key: 246465498
• Report Number: 3013982035-2021-00003
• Device Sequence Number: 1
• Product Code: GHH
• UDI-Device Identifier: 30014613337959
• UDI-Public: (01)30014613337959(10)T11680N(17)210619(11)201005
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2021
• Device Model Number: 97300EU
• Device Catalogue Number: 97300EU
• Device Lot Number: T11680N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1