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

Model Number	97300EU
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: TRIAGE PROFILER SOB PANEL
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 11416728
• Report Number: 3013982035-2021-00003
• Device Sequence Number: 19739237
• Product Code: GHH
• UDI-Device Identifier: 30014613337959
• UDI-Public: (01)30014613337959(10)T11680N(17)210619(11)201005
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1