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 05/01/2015

Event Type  malfunction  

Event Description

Customer's daughter called on behalf of her mother who complains of an e-3 error message, upon troubleshooting a blood result of "lo" was obtained.Customer's daughter states that her mother feels well and requires no medical attention.Customer's expected blood results are 110-110mg/dl fasting.Verified the strips expire 08/31/2017.Customer confirms the strips are stored properly and were first opened (b)(6) 2015.Reviewed meter memory: 53mg/dl, (b)(6) 2015, 09:37:00 am, fasting: no; lomg/dl, (b)(6) 2015, 09:36:00 am, fasting: no; 86mg/dl, (b)(6) 2015, 05:42:00 am, fasting: yes.No adverse event reported.

Manufacturer Narrative

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

• 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: 4808499
• MDR Text Key: 5924355
• Report Number: 1052693-2015-00816
• 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: 05/27/2015

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: RS4630
• 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
• 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: Initial
• Patient Sequence Number: 1