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

Model Number 98100

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 07/16/2015

Event Type  malfunction  

Manufacturer Narrative

The customer did not provide a lot number or return any products for investigation.Since the product(s) associated with the complaint was not returned and a lot number was not provided, manufacturing record review could not be performed and further investigation was not possible.

Event Description

Customer reported having unusually high readings with triage d-dimer test (from 400-1500ng/ml) and then negative results when the patient is scanned.Support specialist visited customer and found that they observe this type of discrepancy with several patients.This is an intermediate care facility and evaluates patents with risk of dvt.A large percent of the population is elderly and this is where they observe this type of discrepancy.When a high result is observed with the triage d-dimer test, the patient is sent for a leg ultrasound scan.If the scan is negative the patients are still put on preventative treatment of daily heparin and continue to be monitored in addition with any other clinical evidence.They understand that elderly population may provide higher concentrations of d-dimer.Additionally they understand the limitation that elderly population may have edema on their legs when scan is completed which may lead to negative results.

• Brand Name: TRIAGE D-DIMER PANEL
• Type of Device: CARDIAC MARKER TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer (Section G): ALERE SAN DIEGO, INC.; 9975 summers ridge rd.; san diego CA 92121
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd.; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4947922
• MDR Text Key: 24648895
• Report Number: 2027969-2015-00543
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 98100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/16/2015
• 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