MAUDE Adverse Event Report: QUIDEL CARDIOVASCULAR INC. TRIAGE D-DIMER PANEL; D-DIMER: FIBRIN SPLIT PRODUCTS

Model Number 98100EU

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 10/23/2017

Event Type  Injury  

Manufacturer Narrative

Customer's complaint was not replicated with in-house testing of retain lot w62838rb.No issues with analyse recovery were observed and the product performed as expected.Manufacturing batch records were reviewed and found that the lot met release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

Event Description

On (b)(6) 2017: patient came to physician due to pain in left leg.Triage d-dimer result was 1240ng/ml.The patient was treated with blood thinner, lixiana and compression.Customer is not questioning this data, only provded as historical information.On (b)(6) 2017: patient came back to physician with pain in left leg.Triage d-dimer result was 1050ng/ml.Due to this result, patient was transferred to angiographgy institue for verification.A ct scan was performed.No deep vein thrombosis was detected.

• Brand Name: TRIAGE D-DIMER PANEL
• Type of Device: D-DIMER: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): QUIDEL CARDIOVASCULAR INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer (Section G): 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: 7085393
• MDR Text Key: 93804403
• Report Number: 2024674-2017-00004
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042890
• 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: 12/05/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2017
• Device Model Number: 98100EU
• Device Lot Number: W62838RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2017
• 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): Other