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

Model Number 98100EU

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: all data results from d-dimer lot w59961rb tested with cm calibrator h were within 2sd of the expected value and d-dimer cv of 7.95% is within the device product insert claim.Reviewed the manufacturing batch records for d-dimer lot w59961rb.No relevant nc's were generated on the lot.During production, further testing was conducted to ensure lot is within specifications for ous release.Lot passed ous 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 with the triage d-dimer device lot.

Event Description

Event occurred in the (b)(6).Email received from customer alleging a recent d-dimer reading showed as negative, the same blood test from the patient went to the lab and the lab reading showed >500.Customer stated they took a sample of blood and analysed through the alere machine, which had been calibrated 3 hours previously.Then the exact same sample was sent to the hospital for other tests but also including d-dimer.The results were very different, d-dimer result was 271, which is a negative result.The lab at (b)(6) hospital had a result of >500 on the very same sample which was positive.There were no reported adverse events related to the triage result.No patient information provided.

• 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: 5128850
• MDR Text Key: 27524497
• Report Number: 2027969-2015-00826
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 98100EU
• Device Lot Number: W59961RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2015
• 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
• Treatment: TRIAGE METERPRO SERIAL #(B)(4)