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 06/30/2015

Event Type  malfunction  

Event Description

Consumer complaint of about blood result reading low.Customer states that he feels well and requires no medical attention.Customer's expected blood results are 70-130mg/dl fasting.Verified the strips expire 02/14/2017.Customer confirms the strips are stored properly and was first opened (b)(6) 2015.Customer performed back to back blood test, 83mg/dl and 37mg/dl fasting.Reviewed meter memory: 33mg/dl, (b)(6) 2015, 05:17:00 am, fasting: yes; 33mg/dl, (b)(6) 2015, 05:14:00 am, fasting: yes; 65mg/dl, (b)(6) 2015, 02:08:00 pm, fasting:yes; 56mg/dl, (b)(6) 2015, 09:09:00 pm, fasting: yes; 29mg/dl, (b)(6) 2015, 01:54:00 pm, fasting: yes.No adverse event reported.

Manufacturer Narrative

(b)(4).Returned meter and test strips evaluated with no defects found.Most likely underlying root cause of malfunction.User's test strip had poor fill.

• 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: 4942219
• MDR Text Key: 6039788
• Report Number: 1052693-2015-01259
• 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: Health Professional
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RR4500
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2015
• 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