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

Model Number 98100

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Thrombosis (2100); Thrombus (2101)

Event Date 06/21/2016

Event Type  Injury  

Manufacturer Narrative

Returned patient sample yielded d-dimer results close to the customer's observed <100 ng/ml when tested in-house with retain lot w60947.Customer's complaint of discrepant low was replicated.Customer's complaint of discrepant low was not replicated with in-house testing of retain lot w60947 and cardiac marker calibrator d.Results were found to be within the package insert claim.Customer's complaint of discrepant low was not replicated with in-house testing of retain lot w60947 and d-dimer elevated donor whole blood.Results were positive for d-dimer.Device lot performed as expected with in-house samples, unable to rule out sample specific interference was a potential cause for discrepant results.Batch records for lot w60947 were reviewed; lot met release specifications; no issues with d-dimer recovery were observed.No product deficiency was established.No corrective action required at this time.

Event Description

On (b)(6) 2016 a (b)(6) female came in to the urgent care reporting redness/purple discoloration to great toe and calf.The triage d-dimer test result was <100ng/ml (range=0.500).The patient went elsewhere to obtain an ultrasound which indicated that there was a blood clot.On (b)(6) 2016 the patient returned to urgent care and the triage d-dimer test was repeated with the same result as the previous day.The patient's sample was sent to the hospital for testing and gave a result of 2.07 mcg/ml feu (range=0-0.5) on the stago compact analyzer.

• Brand Name: ALERE TRIAGE D-DIMER TEST
• 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: 5813873
• MDR Text Key: 50176453
• Report Number: 2027969-2016-00530
• 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: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• 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: 06/23/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 49 YR