MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC. EASY TOUCH; GLUCOSE MONITOR

Catalog Number 807001

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Improper Device Output (2953)

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

Event Date 04/18/2018

Event Type  malfunction  

Event Description

Displays lo and will not give a number.He's been pharmacist for years and knows how to test blood sugar levels.He requested a new meter and new strips because these are not working.

• Brand Name: EASY TOUCH
• Type of Device: GLUCOSE MONITOR
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC.; 11930 kemper springs drive; cincinnnati OH 45240
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC.; 11930 kemper springs drive; cincinnnati OH 45240
• Manufacturer Contact: jennifer seiple ; 11930 kemper springs drive; cincinnnati, OH 45240
• MDR Report Key: 7528281
• MDR Text Key: 108724459
• Report Number: 3005798905-2018-00530
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093492
• 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: 05/18/2018

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: 08/02/2019
• Device Catalogue Number: 807001
• Device Lot Number: 463202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/18/2018
• 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