MAUDE Adverse Event Report: MHC MEDICAL PRODCUTS, LLC. EASY TOUCH; GLUCOSE MONITORING SYSTEM

Catalog Number 807001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 03/14/2018

Event Type  malfunction  

Event Description

Sporadic inaccurate readings.

• Brand Name: EASY TOUCH
• Type of Device: GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): MHC MEDICAL PRODCUTS, LLC.; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer (Section G): MHC MEDICAL PRODCUTS, LLC.; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer Contact: jennifer seiple ; 11930 kemper springs drive; cincinnati, OH 45240
• MDR Report Key: 7653133
• MDR Text Key: 112909522
• Report Number: 3005798905-2018-00951
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073492
• 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: 06/22/2018

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: Lay User/Patient
• Device Expiration Date: 05/09/2019
• Device Catalogue Number: 807001
• Device Lot Number: 461801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2018
• Initial Date FDA Received: 06/29/2018
• 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: Reuse
• Patient Sequence Number: 1