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 04/08/2015

Event Type  malfunction  

Event Description

Consumer complaint of low blood results.Expected blood glucose results fasting range from 75 to 250mg/dl.Comparing blood glucose test results to undisclosed mother's meter and claims results are 30mg/dl lower.Blood test performed using both meters and test result was 286mg/dl with mother's meter and 252 mg/dl with trueresult meter.Back to back blood test not able to be performed during call since test strips do not have proper storage.Verified storage of test strips is within instructed specification since they are kept in kitchen pantry.Test strip lot mfr's expiration date is 05/31/2016 and open vial date is (b)(6) 2015.Recall test results performed fasting from meter memory: 229mg/dl, (b)(6) 2015, 03:21am, 223mg/dl (b)(6) 2015, 07:23am, 129mg/dl, (b)(6) 2015, 01:32pm, 69mg/dl, (b)(6) 2015, 10:28am, 447mg/dl, (b)(6) 2015 ,11:46pm.No adverse event reported.

Manufacturer Narrative

(b)(4).Returned meter evaluated with no defect found.Test strips not returned for eval.Most likely underlying root cause: user had an inaccurate reference, user reused test strip, user's test strip had poor fill, or user's test strip had poor storage.

• 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: 4792502
• MDR Text Key: 20066375
• Report Number: 1052693-2015-00486
• 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: 04/29/2015

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: RP4326
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 04/29/2015
• 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