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

Model Number	TRUETRACK
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report #(b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause of malfunction noted in the complaint: user's test strip had poor fill.Test strip udi#(b)(4).Based on review with fda on 06/21/2017, we verified the agency's interpretation of the act and submit this medwatch report based on the nature of the complaint for this recalled lot.Recall #fda-assigned recall event id (b)(4).
Event or Problem Description
Customer complains of low results.Customer states that she feels well and requires no medical attention.The customer's expected blood result is 125-145mg/dl fasting.Verified the strips expired 10/31/2017.Customer confirms the strips have been properly stored and were first opened (b)(6) 2015.Customer performed a back to back blood test and obtained 94mg/dl and 96mg/dl fasting.Reviewed meter memory the 95mg/dl (b)(6) 2015 01:49:00 pm fasting:yes, the 75mg/dl (b)(6) 2015 01:48:00 pm fasting:yes, the 125mg/dl (b)(6) 2015 09:03:00 am fasting:yes, the 157mg/dl (b)(6) 2015 08:30:00 pm fasting:yes, the 140mg/dl (b)(6) 2015 07:35:00 am fasting:yes, memory concerns:75mg/dl.Customer read a back to back blood test and the meter read 75mg/dl and 95mg/dl.

• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): NIPRO DIAGNOSTICS, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6677251
• Report Number: 1000113657-2017-01125
• Device Sequence Number: 72246
• Product Code: NBW
• UDI-Device Identifier: 00041220842438
• UDI-Public: (01)00041220842438
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/29/2017

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
• Operator of Device: Lay User/Patient
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 06/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1