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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FINGERSTICK DEVICE; LANCET, BLOOD

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FINGERSTICK DEVICE; LANCET, BLOOD 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
FINGERSTICK DEVICE
Type of Device
LANCET, BLOOD
MDR Report Key8700294
MDR Text Key148276225
Report NumberMW5087378
Device Sequence Number1
Product Code FMK
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 Health Professional
Was Device Available for Evaluation? No
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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