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

Model Number TRUETRACK

Device Problem Low Test Results (2458)

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

Event Date 05/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product returned for eval: no defect found.Most likely underlying root cause: user's test strip had a poor storage.

Event Description

Consumer complaint of low blood results.Expected fasting blood glucose test range is 100 to 120 mg/dl.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 128 mg/dl and 116 mg/dl.Verified storage of product is not within instructed specification since they are kept in kitchen.Test strip lot mfr's expiration date is 06/19/2017 and open vial date is (b)(6) 2015.Recall test results performed fasting/non-fasting from meter memory: 130mg/dl (b)(6) 2015 12:06am; 85mg/dl (b)(6) 2015 02:08am; 68mg/dl (b)(6) 2015 12:49am; 89mg/dl (b)(6) 2015 12:55pm; 148mg/dl (b)(6) 2015 12:41pm.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
• MDR Report Key: 4859388
• MDR Text Key: 22515962
• Report Number: 1052693-2015-00929
• 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: 06/18/2015

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: Health Professional
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4580
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/21/2015
• Initial Date FDA Received: 06/18/2015
• 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: Initial
• Patient Sequence Number: 1