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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK-SET PARADIGM UNO QUICK-SET 60/9 SC1 MECA

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QUICK-SET PARADIGM UNO QUICK-SET 60/9 SC1 MECA Back to Search Results
Model Number MMT-397A
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states. On 16-aug-2021, it was reported that the patient experienced confusion, flu like due to high blood glucose levels because the line was damaged and leaking (2-3 inches from the body hole). Further, on (b)(6) 2021, he was admitted to the hospital with blood glucose level of 600-700 mg/dl and diabetic ketoacidosis where intravenous insulin drip was administered as corrective treatment. Reportedly, on (b)(6) 2021 he was released from the hospital. No further information available.
 
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Brand NameQUICK-SET PARADIGM
Type of DeviceUNO QUICK-SET 60/9 SC1 MECA
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key12408545
MDR Text Key269380572
Report Number3003442380-2021-00420
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 Received09/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-397A
Device Lot Number5342481
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2021
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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