MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH GLUCOSE METER KIT; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number 807001

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2018

Event Type  malfunction  

Event Description

Customer claimed that an error message was displayed, but meter shut off too quickly and the customer was unable to see what the code was.A test strip was inserted and the "12hr" would display on the screen, but then would shut off.Meter now does not power on.

• Brand Name: EASYTOUCH GLUCOSE METER KIT
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC.; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer Contact: jennifer seiple ; 11930 kemper springs drive; cincinnati, OH 45240
• MDR Report Key: 7621889
• MDR Text Key: 111837150
• Report Number: 3005798905-2018-02469
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K073492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 807001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1