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

Model Number 809001

Device Problems Computer Software Problem (1112); Computer Operating System Problem (2898); Device Operational Issue (2914); Operating System Becomes Nonfunctional (2996)

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

Event Date 03/07/2018

Event Type  malfunction  

Event Description

Customer claimed that the meter wasn't working: "not accepting blood, and the apple is blinking".

• Brand Name: HEALTHPRO 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: 7621876
• MDR Text Key: 111775951
• Report Number: 3005798905-2018-02457
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K113192
• 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: 809001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2018
• 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