MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. TRIAGE D-DIMER PANEL; FIBRIN SPLIT PRODUCTS

Model Number 98100

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: in-house testing was performed with retains of device lot w62926b; highly elevated d-dimer results were obtained with the customer's returned sample.However, testing with whole blood specimens from in-house donors found no issues with product performance.All replicates for a given donor were consistent with one another and no discrepant results were observed.Sample-specific factors in the returned sample cannot be ruled out as the cause of the complaint.Manufacturing batch records for the lot 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, the patient arrived at the facility feeling poorly and experiencing shortness of breath and chest pressure.The patient was admitted to the emergency department.At 10:15am, a whole blood edta sample was drawn and at 11:16am the triage d-dimer panel produced an abnormal d-dimer result of 1800 ng/ml.The following day, (b)(6) 2017, repeat testing was performed with the same sample and at 11:00am the triage d-dimer panel produced an abnormal d-dimer result of 1790 ng/ml.During the hospitalization, an ekg was performed due to the chest pain and was reported to be negative.The following other cardiac marker results were also received during the hospitalization: troponin= <0.05 ng/ml and bnp= 3670 pg/ml (method not specified).The discharge diagnosis for the patient was reported to be chest pain.The facility's triage d-dimer cutoff was provided as >500 ng/ml.

• Brand Name: TRIAGE D-DIMER PANEL
• Type of Device: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge road; san diego, CA 92121 ; 8588052084
• MDR Report Key: 6946998
• MDR Text Key: 90336370
• Report Number: 2027969-2017-00155
• 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: Health Professional
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2018
• Device Model Number: 98100
• Device Lot Number: W62926B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2017
• 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 Age: 71 YR