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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC HEALTHPRO GLUCOSE METER KIT; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
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MHC MEDICAL PRODUCTS, LLC HEALTHPRO GLUCOSE METER KIT; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER Back to Search Results
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 02/21/2018
Event Type  malfunction  
Event Description
Customer claimed that the strips would not register blood.Customer also described how the date changed on its own, the batteries are always moving and the customer had to use tape to keep them in place.Customer tried troubleshooting and continued to have the same issues.
 
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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 Key7621869
MDR Text Key111774141
Report Number3005798905-2018-02456
Device Sequence Number1
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113192
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 Date07/16/2019
Device Model Number809001
Device Lot NumberV17G175E1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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