MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. KIT, TRIAGE, CARDIAC TNI; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

Model Number	97021HS
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation conclusion: the customer's complaint was not replicated during in-house testing with retains of device lot w63258rb.No issues with analyte recovery were observed.Manufacturing batch records for the lot were reviewed and found that the lot met release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.
Event or Problem Description
The customer was performing a correlation study between the triage system and the dimensions exl analyzer.The following events were reported occurring on one patient: both an edta plasma and a heparin plasma sample was collected from the patient.The plasma samples were collected and stored frozen over the weekend.On (b)(6) 2017, the edta plasma sample was tested using the triage tni panel and produced a normal tni result of 0.19 ng/ml.The heparin plasma sample was tested on the dimensions exl analyzer and produced an abnormal tni result of 0.63 ng/ml.There was no treatment or intervention provided based on the triage tni result.The facility's normal triage tni cutoff was reported to be 0.40ng/ml the facility's normal dimensions exl analyzer tni cutoff was reported to be 0.56ng/ml.

• Brand Name: KIT, TRIAGE, CARDIAC TNI
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 6881606
• Report Number: 2027969-2017-00145
• Device Sequence Number: 18996544
• Product Code: MMI
• UDI-Device Identifier: 00899722002788
• UDI-Public: (01)00899722002788(10)W63258RB(17)180207(11)170524
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K030286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/07/2018
• Device Model Number: 97021HS
• Device Lot Number: W63258RB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1