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

Model Number 98100

Device Problem High Test Results (2457)

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

Event Date 07/13/2015

Event Type  malfunction  

Manufacturer Narrative

No discrepant high results were observed from any devices tested with normal whole blood (wb) donors.Data results from all devices tested produced the same clinical outcome.Reviewed the manufacturing batch records for d-dimer lot w60220b.No issues with d-dimer recovery observed.No non-conformances were generated on the lot during production.Lot passed all final release specifications.As of (b)(6) 2015, this is the only complaint against d-dimer lot w60220b.No sample was returned.Unable to rule out sample specific interference as a potential cause for discrepant results.No product deficiency was established with the triage d-dimer device lot.No corrective action required at this time.

Event Description

A report was received from alere (b)(4) stating they have a customer who is establishing the normal range for d-dimer (500 ddu).The customer reported that in running patients with expected normal values, they are getting high results.They are concerned that it could be the lot number.They performed a methods comparison with the same lot number and it performed very well.The normal range has been done on lot w60220.The qc performed as expected- low: lot 3085 was 579 and high: 3086 was 2910.(b)(6).

• Brand Name: D-DIMER 25 TEST KIT
• 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: 4975745
• MDR Text Key: 24713913
• Report Number: 2027969-2015-00573
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K042890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 07/13/2015

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: W60220B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/05/2015
• 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