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 05/01/2015

Event Type  malfunction  

Event Description

Consumer complaint of high blood results.Customer states that he feels well and requires no medical attention.Customer's expected blood results are 97-120mg/dl fasting.Verified the strips expire 04/30/2017.Customer confirms the strips are stored properly and were first opened (b)(6) 2015.Customer performed back to back blood test, 136mg/dl and 144mg/dl fasting.Reviewed meter memory: 168mg/dl, (b)(6) 2015, 02:02:00 pm, fasting: yes; 147mg/dl, (b)(6) 2015, 02:01:00 pm, fasting: yes; 147mg/dl, (b)(6) 2015, 03:01:00 pm, fasting: yes; 177mg/dl, (b)(6) 2015, 02:45:00 pm, fasting: yes.Customer is comparing the truetrack with his 2 other meters (onetouch ultra).He ran a blood test and the truetrack meter gave 177mg/dl and the competitor meter gave him 149mg/dl at the same time.No adverse event reported.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Product not returned for evaluation.Most likely underlying root cause is: user had an inaccurate reference.

• 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: 4808511
• MDR Text Key: 16862953
• Report Number: 1052693-2015-00820
• 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,consumer
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/28/2015

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: Lay User/Patient
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RR4556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2015
• Initial Date FDA Received: 05/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/16/2015
• 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