MAUDE Adverse Event Report: ALERE SAN DIEGO, INC. TRIAGE PROFILER SOB PANEL 25T; CARDIOPROFILER PANEL

Model Number 97300EU

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation pending.This event is being reported as part number 97300eu is same/similar to 510 (k): k080269.

Event Description

The customer reported the following events occurring on one patient.The customer reported being concerned with the d-dimer results.On (b)(6) 2017, the patient arrived to the emergency department with chest pain.An initial draw was performed and both whole blood and plasma were collected in edta: (b)(6).

Manufacturer Narrative

Investigation conclusion: the customer's complaint was not replicated during in-house testing with retained devices of lot w62463b.No issues with d-dimer recovery were observed.Manufacturing batch records for the lot were reviewed and found that the lot met release specification based on the information available, there is no indication of a product deficiency and no corrective action is required.

• Brand Name: TRIAGE PROFILER SOB PANEL 25T
• Type of Device: CARDIOPROFILER PANEL
• 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: 6725849
• MDR Text Key: 80473857
• Report Number: 2027969-2017-00120
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K080269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

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
• Device Operator: Health Professional
• Device Model Number: 97300EU
• Device Lot Number: W62463B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2017
• Initial Date FDA Received: 07/19/2017
• Supplement Dates Manufacturer Received: 07/25/2017
• Supplement Dates FDA Received: 07/31/2017
• 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
• Treatment: TRIAGE METERPRO, PN 55070, SERIAL# (B)(4); TRIAGE METERPRO, PN 55070, SERIAL# (B)(4); TRIAGE METERPRO, PN 55070, SERIAL# (B)(4)