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

Model Number TRUEBALANCE

Device Problem High Test Results (2457)

Patient Problems Nausea (1970); Dizziness (2194)

Event Date 06/10/2015

Event Type  malfunction  

Event Description

Consumer complaint of high blood glucose results via granddaughter, test result during the call was 596.Expected blood glucose test results are unknown.Customer feels nauseous and observed symptoms of dizziness.Medical intervention is required at the time of the call on (b)(6) 2015.Upon admission to hospital on (b)(6) 2015, customers blood glucose results were 423 mg/dl with hospital's meter.Currently taking medication to manage diabetes.Storage of product not verified.Test strip lot manufacturer's expiration date is 10/31/2016 and open vial date not verified.Meter memory not recalled.

Manufacturer Narrative

Internal report #(b)(4).Product not yet returned for evaluation.

• 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: 4908425
• MDR Text Key: 6538699
• Report Number: 1052693-2015-01066
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• 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: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRUEBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BR4552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2015
• 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
• Patient Outcome(s): Hospitalization