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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 NameQUICK-SET PARADIGM
Type of DeviceUNO 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
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
0 Patients were 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
Device Model NumberMMT-398A
Device Lot Number5321858
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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