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

Model Number 97000HS

Device Problems False Negative Result (1225); Device Issue (2379)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Received email from the emergency room saying triage troponin i was negative and the chemistry analyzer positive for troponin i.The issue occurred on (b)(6), 2015 in which the triage reported a troponin i of <0.05 and the beckman dxi reported the troponin i >0.034.Their normal range is 0.00-0.034.Patient presented to the emergency room with chest pains, sob and coughing up blood., the reference range and cut-offs of all tests/analyzers/meters involved were as follows:.Triage tni: normal = < 0.1 ng/ml; indeterminate = 0.1 - 0.039; critical = >0.04.Beckman access tni: critical = >0.04 ng/ml.Following are the test results and draw/run times for all analytes: tni: triage < 0.05, dxi >0.034 as provided by (b)(6).Alere scientific affairs provided the test results on these dates.Since (b)(6) 2015 triage tni has been < 0.05 on all tests of 17 draws.Access tni ranged from 0.084 initially on (b)(6) 2015 and to 0.116 on (b)(6) 2015 from 8 draws.Triage ckmb, myo below threshold.Bnp from 233 to 384.No medical interventions were reported based on the results.Lab tni test was performed.Emergency room diagnosis was unstable angina, angina, anxiety.Patient was discharged from the emergency room with a discharge diagnosis of chest pain and warfarin overdose.No death or injuries were reported as a result of the "false" triage tni result? no additional information provided.

Manufacturer Narrative

Investigation conclusion: retained devices tested with cal j did not produce low tni results; cv results at 9.1%, which meets cardiac product insert claim.The customer's complaint of discrepant low tni was not replicated.The product performed as expected.Batch record review found no relevant ncs or tifs; this product passed all specifications for final lot release.No sample was returned to product support; cannot rule out sample interference as the cause of the complaint.No product deficiency was established.Alere triage does not have a claim to correlate with other non-alere analyzers.

• Brand Name: TRIAGE CARDIAC TRIPLE MARKER 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: 5199083
• MDR Text Key: 30612097
• Report Number: 2027969-2015-00893
• Device Sequence Number: 1
• Product Code: NBC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97000HS
• Device Lot Number: W59868B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2015
• 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
• Patient Age: 40 YR