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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCENSIA DIABETES CARE US INC. MICROLET; BLOOD GLUCOSE LANCETS
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ASCENSIA DIABETES CARE US INC. MICROLET; BLOOD GLUCOSE LANCETS Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Needle Stick/Puncture (2462)
Event Date 05/26/2017
Event Type  Injury  
Manufacturer Narrative
The product information (d4) was not provided.The manufacture date could not be determined and lancets are not 510(k) cleared.
 
Event Description
The caller stated an employee in their restaurant was accidentally punctured with a used microlet lancet left by an unknown customer.The employee immediately washed his hands with antibacterial soap and applied alcohol.He went to the hospital where his blood was drawn for further testing.He was given medication to take.Specifics were not provided.
 
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Brand Name
MICROLET
Type of Device
BLOOD GLUCOSE LANCETS
Manufacturer (Section D)
ASCENSIA DIABETES CARE US INC.
430 s. beiger st.
mishawaka IN 46544
Manufacturer (Section G)
ASCENSIA DIABETES CARE US INC.
430 s. beiger st.
mishawaka IN 46544
Manufacturer Contact
jeri messmore
430 s. beiger st.
mishawaka, IN 46544
5742567719
MDR Report Key6651904
MDR Text Key77898713
Report Number1826988-2017-00197
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 Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 05/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/26/2017
Initial Date FDA Received06/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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