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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLOOD GLUCOSE METER; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
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BLOOD GLUCOSE METER; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2019
Event Type  malfunction  
Event Description
I was seeing a dr and noticed that facility was re-using finger stick device and blood glucose meter.Fda safety report id# (b)(4).
 
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Brand Name
BLOOD GLUCOSE METER
Type of Device
SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
MDR Report Key8700294
MDR Text Key148276225
Report NumberMW5087378
Device Sequence Number2
Product Code NBW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 06/11/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age51 YR
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