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

Model Number 98100

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w64947b.No issues with d-dimer recovery were observed, lot performed properly.Manufacturing batch records for the lot were reviewed, lot met release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.Available patient data does not suggest that a positive d-dimer result was expected.

Event Description

On 05/2019 initial draw at 7:40pm, sample ran at 9:03pm on two meters- triage d-dimer result of <100 ng/ml on both meters and lab acl result of 977 ng/ml.Bnp was elevated at 268pg/ml.Tni was slightly elevated at 0.05ng/ml.Hematocrit 43.9%.On 05/20- redraw.Triage d-dimer result was still <100ng/ml and acl was 887ng/ml.On 05/21- patient discharged and sent home awake and alert with no signs of distress.Patient had come in weak and with shortness of breath.Admitting diagnosis was weakness and shortness of breath with an overall impression of known copd and cardiac arrhythmias.Customer unable to provide discharge diagnosis.Customer unsure of what treatments were administered but thinks patient was provided with breathing treatments and medication prior to discharge.No further information provided.Acl cutoff= 200-5250ng/ml over 230 they consider critical.Customer called acl and they could not provide any explanation for the discrepancy on their end.Treatment and medical decisions were made based off the acl result.

• 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
• Manufacturer Contact: jessica perrotte ; 9975 summers ridge road; san diego, CA 92121 ; 8583020297
• MDR Report Key: 8710195
• MDR Text Key: 148427506
• Report Number: 3013982035-2019-00011
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042890
• 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: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/19/2019
• Device Model Number: 98100
• Device Lot Number: W64947B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2018
• 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