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

Model Number TRUE RESULT

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 06/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product not yet returned for eval.

Event Description

Consumer complaint of high blood results.Expected blood glucose test result range after meal is 145 mg/dl.Testing performed four times daily.Customer feels well and observed no symptoms.Medical intervention is not required at this time.Currently taking insulin to manage diabetes.Back to back blood test performed fasting during call on (b)(6) 2015 produced results of 250 mg/dl and 222 mg/dl.Verified storage of product is not within instructed spec since they are kept in customer's purse.Test strips lot mfr's expiration date is 01/22/2017 and open vial date is (b)(6) 2015.Recall test results performed non-fasting from meter memory: 247mg/dl (b)(6) 2015 02:23pm; 230mg/dl (b)(6) 2015 03:48pm; 552mg/dl (b)(6) 2015 03:49pm; 350mg/dl (b)(6) 2015 03:48pm; 357mg/dl (b)(6) 2015 03:23pm.Adverse event not reported.

• Brand Name: TRUE TRACK
• 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: 4894440
• MDR Text Key: 23113431
• Report Number: 1052693-2015-01011
• 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: 06/25/2015

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: TRUE RESULT
• Device Catalogue Number: A4H01-81
• Device Lot Number: RR4484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2015
• 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