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

Model Number	97000HS
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation pending.
Event or Problem Description
The customer reported the following events occurring on one patient: on (b)(6) 2017, the patient walked into the emergency department with a high fever and was admitted.Both an edta plasma sample and a heparin plasma sample were collected from the patient.The edta plasma sample was tested using the triage cardiac triple marker panel and produced a tni result of <0.05 ng/ml.The heparin plasma sample was tested using the siemens exl and produced a tni result of 0.104 ng/ml.The customer provided the following reference ranges: <0.056 ng/ml (negative); 0.057-0.099 ng/ml (intermediate risk); >0.100 ng/ml (high risk).The customer is unable to provide any information regarding the diagnosis of the patient.However, no treatment or intervention was administered or withheld based on the triage tni result.As of (b)(6) 2017, the patient had not been discharged.
Additional Manufacturer Narrative
Investigation conclusion: the customer's complaint was not replicated with in-house testing of retain lot w62705b.No issues with tni recovery were observed.The customer returned 1 device of lot w62705b which is not sufficient for an investigation therefore it was not tested.Manufacturing batch records for lot w62705b were reviewed and found that the lot met final release specifications.Based on the information available, there is no indication of a product deficiency and no corrective action is required.

• Brand Name: TRIAGE CARDIAC TRIPLE MARKER PANEL
• Common Device Name: TRIAGE CARDIAC PANEL
• Manufacturer (Section D): ALERE SAN DIEGO, INC.; 9975 summers ridge road; san diego CA 92121
• MDR Report Key: 6542033
• Report Number: 2027969-2017-00078
• Device Sequence Number: 616571
• Product Code: MMI
• UDI-Device Identifier: 00893038002197
• UDI-Public: (01)00893038002197(10)W62705B(17)170920(11)170106
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 04/24/2017

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 Model Number: 97000HS
• Device Lot Number: W62705B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 05/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1