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  

Event Description

Consumer complaint of high blood glucose results.Expected fasting blood glucose test result range is 118 to 120 mg/dl.Customer feels well and observed no symptoms.Medical intervention is not required at the time of the call on (b)(6) 2015.Currently taking medication to manage diabetes.Back to back blood test performed fasting produced results of 403 mg/dl, 311mg/dl, and 365 mg/dl.Back to back blood test performed fasting during call on (b)(6) 2015 produced results of 334 mg/dl and 299 mg/dl.Verified storage of product is within instructed specification.Test strip lot manufacturer's expiration date is 11/21/2016 and open vial date is (b)(6) 2015.Recall test results performed fasting from meter memory: 365mg/dl (b)(6) 2015 12:04pm; 311mg/dl (b)(6) 2015 12:01pm; 403mg/dl (b)(6) 2015 08:58am; 198mg/dl (b)(6) 2015 07:49pm; 373mg/dl (b)(6) 2015 08:52am; adverse event not reported.

Manufacturer Narrative

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

• 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: 4894476
• MDR Text Key: 18777670
• Report Number: 1052693-2015-01058
• 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: RR4540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/09/2015
• 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