MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR INC. TRIAGE PROFILER SOB PANEL (25T); CARDIOPROFILER PANEL

Model Number 97300EU

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 12/22/2017

Event Type  Injury  

Manufacturer Narrative

The customer's complaint was not replicated with in-house testing of retain lot w63103b.No measurement failures were observed and the product performed as expected.Manufacturing batch records for lot w63103b were reviewed and found the lot met final release specifications and showed no measurement failures at final release.A device deficiency cannot be substantiated.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

The customer reported receiving two measurement failure error messages while testing a patient sample on the triage meter sn (b)(4) and triage profiler sob panel lot number w63103b.The customer stated there was a white coating on the edta blood sample.The customer was advised to centrifuge the sample and attempt to test again using plasma.However, while the sample was in the centrifuge, the patient was rushed to the hospital with suspicion of pulmonary embolism (pe).The customer stated that the patient's symptoms became more severe while attempting to obtain valid triage results.The measurement failures may have caused a delay in patient treatment.

• Brand Name: TRIAGE PROFILER SOB PANEL (25T)
• Type of Device: CARDIOPROFILER 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 ; 8588053573
• MDR Report Key: 7207472
• MDR Text Key: 97848695
• Report Number: 3013982035-2018-00002
• Device Sequence Number: 1
• Product Code: DAP
• 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,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2018
• Device Model Number: 97300EU
• Device Lot Number: W63103B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 23 YR