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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC. EASY TOUCH; GLUCOSE MONITORING SYSTEM
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MHC MEDICAL PRODUCTS, LLC. EASY TOUCH; GLUCOSE MONITORING SYSTEM Back to Search Results
Catalog Number 807001
Device Problems Display or Visual Feedback Problem (1184); Unable to Obtain Readings (1516); Device Issue (2379)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/14/2018
Event Type  malfunction  
Event Description
Readings not displaying only date and time.(b)(6) (home nurse) ; called in behalf of her patient.When the strip is inserted the meter won't read the strips.The time and date just shows on the screen.
 
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Brand Name
EASY TOUCH
Type of Device
GLUCOSE MONITORING SYSTEM
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 Key7617138
MDR Text Key111635423
Report Number3005798905-2018-00598
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K073492
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Home Health Aide
Remedial Action Replace
Type of Report Initial
Report Date 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date08/29/2019
Device Catalogue Number807001
Device Lot Number463502
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/14/2018
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 Number1
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