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

Model Number TRUEBALANCE

Device Problem High Test Results (2457)

Patient Problems Urinary Frequency (2275); Polydipsia (2604)

Event Date 06/22/2015

Event Type  malfunction  

Event Description

Consumer complaint of high blood glucose results.Expected fasting blood glucose test result range is 150 mg/dl.Customer feels well but did observe symptoms of dry mouth and frequent urination previously.Medical intervention due to meter's results is not required at the time of the call on (b)(6) 2015.Currently taking medication to manage diabetes.Verified storage of product is not within instructed spec since they are kept in kitchen.Test strip lot manufacturer's expiration date is 08/21/2016 and open vial date is week of (b)(6) 2015.Recall test results performed fasting from meter memory: 1: 170 mg/dl, (b)(6) 2015, 02:00 pm; 2: 360 mg/dl, (b)(6) 2015, 02:24 am; 3: 212 mg/dl, (b)(6) 2015, 03:05 am; 4: 146 mg/dl, (b)(6) 2015, 08:36 pm; 5: 228 mg/dl, (b)(6) 2015, 03:48 pm.Adverse event not reported.

Manufacturer Narrative

(b)(4).Product not yet returned for eval.

• Brand Name: TRUEBALANCE
• 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: 4924399
• MDR Text Key: 20150982
• Report Number: 1052693-2015-01193
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• 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

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRUEBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BR4504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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