MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. TRIAGE D-DIMER PANEL; CARDIAC MARKER TEST

Model Number 98100

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/09/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: d-dimer data results from all lot w60284b devices tested with cm calibrator h were within 2sd of the expected value and a d-dimer cv of 4.76% is within final release testing specifications.Reviewed the batch record of lot w60284b.No issues with d-dimer recovery observed.No ncs or tifs were generated during manufacturing.Lot met all final release specifications.No sample was returned.Unable to rule out sample specific interference as a potential cause for discrepant results.No product deficiency was established.

Event Description

Discrepant low d-dimer, edta whole blood tested x 1, 234 (cut-off 500), patient diagnosed with subclavian thrombosis at another facility via ultrasound.Customer stated patient tested for d-dimer with edta wb sample, obtained "negative" result x 1, 234 ng/ml (customer cut-off 0 - 500 ng/ml), dln w60284.Qcd passed successfully on 10/9, d-dimer controls were last run successfully on (b)(6) 2015.Customer states patient, (b)(6) male who works outdoors, came into emergency department with arm injury/pain/swelling.No other medical history or known co-morbidities.No known medications.Comprehensive metabolic panel was also drawn for testing, essentially normal except for mildly elevated glucose.Patient had slightly elevated blood pressure, normal temperature and o2 saturation.There were no concerns about sample quality, no hemolysis, lipemia or clots.Patient was tested and released with a discharge diagnosis of tendonitis.Patient went to different emergency department where he was diagnosed with subclavian thrombosis via ultrasound.Although requested, no additional information received.

• Brand Name: TRIAGE D-DIMER PANEL
• Type of Device: CARDIAC MARKER TEST
• 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: 5212844
• MDR Text Key: 30843197
• Report Number: 2027969-2015-00914
• Device Sequence Number: 1
• Product Code: DAP
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2015

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
• Device Operator: Health Professional
• Device Model Number: 98100
• Device Lot Number: W60284B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2015
• Initial Date FDA Received: 11/09/2015
• 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: 47 YR