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 07/01/2015

Event Type  malfunction  

Event Description

Consumer complaint of high blood glucose results.Expected fasting blood glucose test result range is 84 to 93 mg/dl.Testing performed three times daily.Customer feels well and observed no symptoms.Medical intervention due to meter's results is not required at the time of the call on (b)(6) 2015.Currently taking insulin to manage diabetes.Back to back blood test performed fasting during call on (b)(6) 2015 produced results of 143 mg/dl and 126 mg/dl.Verified storage of product is within instructed spec.Test strip lot manufacturer's expiration date is 12/31/2015 and open vial date is week of (b)(6) 2015.Recall test results performed fasting from meter memory: 1: 96 mg/dl, (b)(6) 2015, 09:18 am; 2: 115 mg/dl, (b)(6) 2015, 09:16 am; 3: 141 mg/dl, (b)(6) 2015, 12:13 am; 4: 162 mg/dl, (b)(6) 2015, 12:12 am; 5: 125 mg/dl, (b)(6) 2015, 11:16 pm.Adverse event not reported.

Manufacturer Narrative

Internal report (b)(4).Product not yet evaluated.

• 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: 4942225
• MDR Text Key: 15830584
• Report Number: 1052693-2015-01272
• 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: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• 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: RP4228
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer 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