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 05/09/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Consumer complaint of high blood results.Expected fasting blood result range is 90 to 100mg/dl.Customer feels well and observed no symptoms.Medical intervention is not required at this time.Currently taking medication and insulin to manage diabetes.Back to back blood test declined.Verified storage of test strips is within instructed specification.Test strip lot manufacturer's expiration date is 08/18/2017 and open vial date is (b)(6) 2015.Recall test results performed fasting from meter memory: 1:128mg/dl, (b)(6) 2015, 10:27 am.2:133mg/dl, (b)(6) 2015, 01:00 am.3:140mg/dl, (b)(6) 2015, 07:59 am.4:232mg/dl, (b)(6) 2015, 12:00 am.5:147mg/dl, (b)(6) 2015, 09:36 am.Adverse event not reported.

Manufacturer Narrative

(b)(4).Product not returned for evaluation.Most likely underlying root cause is: user's test strip had poor storage.

• 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: 2400 n.w. 55th ct.; fort lauderdale, FL 33309 ; 9546779201
• MDR Report Key: 4824617
• MDR Text Key: 22381389
• Report Number: 1052693-2015-00855
• 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,consumer
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/04/2015

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: Lay User/Patient
• Device Model Number: TRUEBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BS4613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2015
• Initial Date FDA Received: 06/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/16/2015
• 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