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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK-SET PARADIGM; UNO QUICK-SET 110/6 SC1 MECA
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QUICK-SET PARADIGM; UNO QUICK-SET 110/6 SC1 MECA Back to Search Results
Model Number MMT-398A
Device Problem Material Twisted/Bent (2981)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4).Event occurred in the united states on (b)(6) 2021, it was reported that the patient experienced diabetic ketoacidosis due to bad infusion sets, as 6 of the sets were bent and insulin did not leak.Further, they tried to treat this with a manual injection/ insulin.Subsequently, on (b)(6) 2021, she was hospitalized with blood glucose level of 600 mg/dl and diabetic ketoacidosis, where she was administered intravenous insulin infusion as corrective treatment.Currently, she was in the hospital for three days.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.
 
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Brand Name
QUICK-SET PARADIGM
Type of Device
UNO QUICK-SET 110/6 SC1 MECA
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key12022849
MDR Text Key257147204
Report Number3003442380-2021-00284
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244017931
UDI-Public05705244017931
Combination Product (y/n)Y
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date06/01/2023
Device Model NumberMMT-398A
Device Lot Number5321858
Date Manufacturer Received06/10/2021
Type of Device Usage N
Patient Sequence Number1
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