MAUDE Adverse Event Report: ALERE SAN DIEGO, INC D-DIMER 25 TEST KIT; CARDIAC MARKER TEST

Model Number 98100

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2014

Event Type  malfunction  

Event Description

Caller reports receiving the e4 error code on two different pt samples.Customer then ran l1 contols and got an internal qc error.

Manufacturer Narrative

This device lot was recalled due to potential performance issue.Refer to (b)(4).

• Brand Name: D-DIMER 25 TEST KIT
• Type of Device: CARDIAC MARKER TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 3884150
• MDR Text Key: 21804018
• Report Number: 2027969-2014-00452
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 05/07/2014

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 Catalogue Number: 98100
• Device Lot Number: W53884B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2014
• Initial Date FDA Received: 05/19/2014
• 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
• Removal/Correction Number: FCA-008-14
• Patient Sequence Number: 1