MAUDE Adverse Event Report: NIPRO DIAGNOSTICS, INC. TRUETRACK; BLOOD GLUCOSE SYSTEM

Model Number TRUETRACK

Device Problem Low Test Results (2458)

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

Event Date 06/26/2014

Event Type  malfunction  

Event Description

Consumer complaint of e-3 error; test strip error.Investigation of returned test strips produced e-3 error.Test strip lot mfr's expiration date is 06/13/2015 and open vial date is not verified.No adverse event reported.

Manufacturer Narrative

(b)(4).Returned test strips evaluated with defect found; showed indication of black chemistry.Most likely underlying root cause of malfunction noted in the complaint: improper storage of test strip in high humidity areas.Mfr acknowledges lateness of the report, per internal corrective action.This report should have been identified as reportable within 30 days of the identification ((b)(6) 2014).

• Brand Name: TRUETRACK
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): NIPRO DIAGNOSTICS, INC.; 2400 n.w. 55th ct.; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 n.w. 55th ct.; fort lauderdale, FL 33309 ; 9546779201
• MDR Report Key: 4908374
• MDR Text Key: 21767806
• Report Number: 1052693-2015-01127
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/09/2015

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: Lay User/Patient
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RN4080
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/11/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2014
• Initial Date FDA Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1