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

Model Number TRUETRACK

Device Problem High Test Results (2457)

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

Event Date 06/09/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product returned for evaluation: no defect found.Most likely underlying root cause: user had an inaccurate reference.

Event Description

Consumer complaint of high blood glucose results.Expected fasting blood glucose test result range is 130 to 145 mg/dl.Testing performed twice daily; morning and night.Customer feels well and observed no symptoms.Medical intervention is not required at the time of the call on (b)(6) 2015.Back to back blood test declined at time of call on (b)(6) 2015.Currently taking insulin to manage diabetes.Verified storage of product is within instructed specification since they are kept in living room.Test strip lot manufacturer's expiration date is 06/22/2017 and open vial date is (b)(6) 2015.Recall test results performed from meter memory: 275mg/dl (b)(6) 2015 11:48am fasting:yes; 302mg/dl (b)(6) 2015 11:47am fasting:no; 237mg/dl (b)(6) 2015 11:37am fasting:yes; 267mg/dl (b)(6) 2015 11:11am fasting:yes; 283mg/dl (b)(6) 2015 10:21am fasting:yes; adverse event not reported.

• Brand Name: TRUETRACK
• 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: 4894451
• MDR Text Key: 23114149
• Report Number: 1052693-2015-01059
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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