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

Model Number TRUETRACK

Device Problem High Test Results (2457)

Patient Problems Urinary Frequency (2275); Shaking/Tremors (2515)

Event Date 03/31/2015

Event Type  malfunction  

Event Description

Consumer complaint of blood results reading "hi".Customer states that she feels thirsty, a little bit shaky, and is urinating frequently.I advice customer to seek medical attention, customer agreed and also stated she is not always complying with doctors instructions and that she has not tested her blood sugar for prolonged periods of times.Customer's states she can range from 100-150mg/dl.Customer states she eats throughout the day and evening and that the results obtained are not fasting.Verified the strips expire 03/31/2017.Customer confirms the strips are stored on top of the kitchen table and were first opened (b)(6) 2015.Reviewed meter memory: (b)(6) 1:49pm hi; (b)(6) 4:36pm 292mg/dl; (b)(6) 1:37pm 506mg/dl; (b)(6) 2:12pm 301mg/dl; (b)(6) 09:54am 223mg/dl.Based on the "hi" results seen in the memory, the complaint is reportable.

Manufacturer Narrative

(b)(4).Actual device evaluated and no defect was found.Most likely underlying root cause of malfunction noted in the complaint: user has high glucose value.

• 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: 4730224
• MDR Text Key: 5703365
• Report Number: 1052693-2015-00619
• 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: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• 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: RR4534
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2015
• 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