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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH GLUCOSE TEST STRIPS; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
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MHC MEDICAL PRODUCTS, LLC EASYTOUCH GLUCOSE TEST STRIPS; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER Back to Search Results
Model Number 807050
Device Problems Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975); Physical Property Issue (3008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2018
Event Type  malfunction  
Event Description
On (b)(6) 2018, a pharmacy called on the behalf of a customer who had purchased 4 x 50ct vials and claimed that 1 out of the 4 had defective strips/ defective microchip.
 
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Brand Name
EASYTOUCH GLUCOSE TEST STRIPS
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 Key7621875
MDR Text Key111773495
Report Number3005798905-2018-02463
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 consumer
Reporter Occupation Patient
Remedial Action Replace
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 Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/27/2019
Device Model Number807050
Device Lot Number461804
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/30/2018
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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