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

Model Number 97000HS

Device Problems Device Issue (2379); Low Test Results (2458)

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

Event Date 08/25/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: investigation pending.

Event Description

Nurse called alleging discrepant low tni for one patient.(b)(6) 2015 patient was currently hospitalized.Date of hospital admission, diagnosis, and treatment not provided.During hospitalization, the following tni results were obtained.(b)(6) 2015 at 8:27am; lab tni=0.087; (b)(6) 2015 at 3:12pm; triage tni<0.05; (b)(6) 2015 at 9:00pm; lab tni=0.127.(b)(4).Although requested, no patient or hospitalization details were provided.

Manufacturer Narrative

Investigation conclusion: retain devices of cardiac lot w59739rb tested with the returned patient sample both resulted in tni=<0.05ng/ml.The beckman accessii analyzer resulted in tni=0.05ng/ml confirming the triage cardiac result.Retained devices from cardiac lot w59739rb were previously tested with calibrator j.Data results from all devices yielded a cv 8.4% for tni; within the package insert claim.The product performed as expected during calibrator testing.Reviewed the manufacturing batch records for cardiac lot w59739rb.No issues with tni recovery observed.No ncs or relevant tifs were generated on the lot during production.Lot passed all final release specifications.No product deficiency was established with the triage cardiac device lot.

• 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: 5098209
• MDR Text Key: 26854379
• Report Number: 2027969-2015-00697
• 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: Health Professional
• Type of Report: Followup
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• 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: W59739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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