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

Model Number TRUETRACK

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2014

Event Type  malfunction  

Event Description

Consumer called.Meter lcd display shows partial characters.No adverse event reported.

Manufacturer Narrative

(b)(4).Returned product sows some lcd characters missing, which may cause incorrect interpretation of meter results.Most likely underlying root cause of malfunction: meter dropped/impacted/stressed enough to break lcd.

• Brand Name: TRUETRACK
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): NIPRO DIAGNOSTICS, INC.; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 n.w. 55th ct.; fort lauderdale, FL 33309 ; 9546779201
• MDR Report Key: 4223681
• MDR Text Key: 5071986
• Report Number: 1052693-2014-00231
• 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
• Type of Report: Initial
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RP4253
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2014
• 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