MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. KIT, TRIAGE, CARDIAC TNI; CARDIAC MARKET TEST

Model Number 97021HS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

Customer alleging discrepant low tni when wb patient sample was run on meter (b)(4) at <0.05 - pos on siemens at 0.510; pos on meter (b)(4) at 0.13 (triage tni cutoff of 0.05).Customer alleging there was a meter that wasn't working.She had no details but there was a patient sample run on one meter and was neg for tni.Same sample run on other meter was pos.Alternate method showed tni at "30x the amount." customer mentioned controls ran lower on that one meter.No details provided.Qcd passed.No reported adverse patient sequela.No additional information provided.

Manufacturer Narrative

Investigation pending.

• Brand Name: KIT, TRIAGE, CARDIAC TNI
• Type of Device: CARDIAC MARKET TEST
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; san diego CA
• Manufacturer Contact: ya-ling king ; 9975 summers ridge rd; san diego, CA 92121 ; 8588052084
• MDR Report Key: 4278542
• MDR Text Key: 20123816
• Report Number: 2027969-2014-01019
• Device Sequence Number: 1
• Product Code: GJS
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97021HS
• Device Lot Number: W58300RB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2014
• Initial Date FDA Received: 11/18/2014
• 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