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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 Device Contamination with Body Fluid (2317)
Patient Problem Needle Stick/Puncture (2462)
Event Date 11/30/2018
Event Type  Injury  
Manufacturer Narrative
The patient/family was the initial reporter, so personal information was not entered.Were left blank as the customer age and weight is unknown.The product information was not provided.The manufacture date could not be determined and lancets are not cleared.
 
Event Description
The advocate reported that the customer received an accidental finger stick with a lancing device that had a microlet lancet in it.The lancing device did not belong to the customer.The customer does not have diabetes and found the lancing device in his school.The advocate was advised that the customer should seek medical assistance.The product information was not provided.The advocate refused to return the lancing device for evaluation.
 
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Brand Name
MICROLET
Type of Device
BLOOD GLUCOSE LANCETS
Manufacturer (Section D)
ASCENSIA DIABETES CARE US INC.
100 summit lake drive
valhalla NY 10595
Manufacturer (Section G)
ASCENSIA DIABETES CARE US INC.
100 summit lake drive
valhalla NY 10595
Manufacturer Contact
shweta gulati
100 summit lake drive
valhalla, NY 10595
9142962901
MDR Report Key8142617
MDR Text Key129633090
Report Number1810909-2018-00124
Device Sequence Number1
Product Code FMK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2018
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
Date Manufacturer Received11/30/2018
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 Unknown
Patient Sequence Number1
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