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 06/08/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product under evaluation.

Event Description

Consumer complaint of blood result reading of "hi".Customer states that he feels well and requires no medical attention.Customer's expected blood results are 167-170mg/dl fasting.Verified the strips expire 10/31/2015.Customer confirms the strips are stored in the bathroom closet and were first opened (b)(6) 2015.Reviewed meter memory: 302mg/dl (b)(6) 2015 11:22:00 pm fasting:no; 165mg/dl (b)(6) 2014 02:55:00 pm fasting: no; hi (b)(6) 2014 02:54:00 pm fasting:no; 47mg/dl (b)(6) 2015 12:00:00 am fasting:no; 259mg/dl (b)(6) 2015 10:15:00 pm fasting:no; the meter time and date is not set.The tests done on his meter are non fasting.Adverse event not reported.

• 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: 4894468
• MDR Text Key: 23113780
• Report Number: 1052693-2015-01047
• 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: 06/29/2015

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: BP4298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 07/01/2015
• 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