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

Model Number 98100

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2016

Event Type  malfunction  

Manufacturer Narrative

Customer's complaint of discrepant low was replicated with in-house testing of retain lot w60947 and return patient sample.Results were less than 600 ng/ml and below the threshold for "abnormal results." the alere triage d-dimer test presents values in d-dimer units (d-du).There are no international standards for d-dimer and different assays use antibodies with differing specificities for d-dimer and other fibrin degradation products.It is commonly accepted that 1 d-du = 2 feu.The lack of standardization and differing antibody configurations reduces the reliability of this conversion factor.The customer's triage d-dimer result of 416 ng/ml would have provided an feu result of 0.832 mcg/ml and would be in line with their stago star analyzer result.Triage d-dimer is not claimed to correlate with stago star analyzer.The manufacturing records for the lot were reviewed and the lot met release specifications.No product deficiency was established; no corrective action required at this time.

Event Description

Customer reported discrepant d-dimer results with triage d-dimer panel vs.Hospital analyzer.Bnp testing was also performed and yielded the same results at urgent care and the hospital.A (b)(6) female patient came into urgent care with dyspnea, light-headedness, dizziness.Patient was tested using triage d-dimer with normal result.The customer sent samples to the hospital for testing.Testing was performed on (b)(6) and the hospital analyzer yielded positive results.Due to the elevated d-dimer result, the patient was sent to the er for a ct scan.The d-dimer was repeated yielding a 'normal' result.The er elected not to perform a ct scan since the d-dimer was normal.The er performed a chest x-ray.Patient was discharged and the er planned a follow up with the patient to include an echocardiogram.

• 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: 5881008
• MDR Text Key: 52290394
• Report Number: 2027969-2016-00568
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• 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: W60947B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/20/2016
• 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: 44 YR