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

Model Number TRUEBALANCE

Device Problem High Test Results (2457)

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

Event Date 06/30/2015

Event Type  malfunction  

Event Description

Consumer complaint of high blood glucose results.Expected fasting blood glucose test result range is 130 to 160 mg/dl.Customer feels well and observed no symptoms.Medical intervention due to meter's results is not required at the time of the call on (b)(6) 2015.Currently taking medication and insulin to manage diabetes.Comparing blood glucose test results from truebalance meter to emergency medical services' meter.On (b)(6) 2015, customer performed blood glucose test and obtained test result of 499 mg/dl using truebalance meter.Customer sought medical attention based on this result.When emergency medical services arrived they performed blood glucose test with their meter and rec'd result of 269 mg/dl.Verified storage of product is not within instructed spec.Test strip lot manufacturer's expiration date is 10/23/2017 and open vial date is week of (b)(6) 2015.Recall test results performed from meter memory: 1: 499 mg/dl, (b)(6) 2015, 09:14 pm, fasting: yes; 2: 357 mg/dl, (b)(6) 2015, 07:32 pm, fasting: yes; 3: 306 mg/dl, (b)(6) 2015, 06:39 am, fasting: yes; 4: 333 mg/dl, (b)(6) 2015, 06:11 pm, fasting: no.

Manufacturer Narrative

(b)(4).No product yet returned.

• 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: 4942224
• MDR Text Key: 6190339
• Report Number: 1052693-2015-01266
• 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: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• 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: BS4661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2015
• 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