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 04/21/2015

Event Type  malfunction  

Event Description

Customer complaint of e-5 error.Customer feels well and does not required medical attention.Customer states e-5 error appear after sample is applied.Customer declined a blood test.Verified the strips expired 6/29/2017 unable to confirm the open date of test strips of the storage conditions.Customer stores strips in the kitchen.No adverse event reported.

Manufacturer Narrative

(b)(4).Returned meter evaluated: missing rubber cover over mode switch.Root cause: user mechanical stress.Returned test strips produced "low" readings.Most likely underlying root cause of malfunction noted in the complaint: black chemistry due to improper 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 ; 9546779201
• MDR Report Key: 4771997
• MDR Text Key: 5780449
• Report Number: 1052693-2015-00712
• 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: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• 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: RS4583
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2015
• 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: Unknown
• Patient Sequence Number: 1