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

Model Number TRUE TRACK

Device Problem High Test Results (2457)

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

Event Date 06/19/2015

Event Type  malfunction  

Event Description

Consumer complaint of high blood results.Home health aid of customer states that she feels well and requires no medical attention.Customer's expected blood results are 100-180mg/dl fasting.Verified the strips expire 09/30/2017.Customer confirms the strips are stored properly and was first opened 06/03/2015.Customer performed back to back blood test, 389mg/dl and 401mg/dl not fasting.Reviewed meter memory: 437mg/dl, (b)(6) 2015, 03:14:00 pm fasting: no; 274mg/dl, (b)(6) 2015, 11:58:00 am, fasting yes; 301mg/dl, (b)(6) 2015, (b)(6) 2015, 08:21:00 pm, m fasting: no; 307mg/dl, (b)(6) 2015, 11:33:00 am, fasting: yes; 349mg/dl (b)(6) 2015 11:59:00 pm, fasting: yes.Customer stated today (b)(6) 2015 at noon the meter read blood sugar with their meter and the result was 355mg/dl, customer refuse to go to the hospital stating she was feeling well.Customer after a meal glucose should be no more than 400mg/dl.No adverse event reported.

Manufacturer Narrative

(b)(4).Returned meter and test strips evaluated with no defects found.Most likely underlying root cause.User had inaccurate reference.

• Brand Name: TRUE TRACK
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): NIPRO DIAGNOSTICS, INC.; 2400 n.w. 55th ct.; fort lauderdale FL 33309
• Manufacturer Contact: karen devindent ; 2400 n.w. 55th ct.; fort lauderdale, FL 33309 ; 9546779201
• MDR Report Key: 4924469
• MDR Text Key: 6055160
• Report Number: 1052693-2015-01161
• 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: Nurse
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/16/2015

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: Health Professional
• Device Model Number: TRUE TRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4649
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/30/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 07/16/2015
• 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