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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK SET PARADIGM; UNO QUICK-SET 60/6 SC1 MECA
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QUICK SET PARADIGM; UNO QUICK-SET 60/6 SC1 MECA Back to Search Results
Lot Number UNKNOWN
Device Problem Infusion or Flow Problem (2964)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4).Event occurred in the united states on (b)(6) 2024, it was reported that the patient got insulin flow blocked alarm.On the morning of (b)(6) 2024 (friday), the patient was not feeling well, started throwing up and got a message of blocked site.Therefore, the patient changed site but again got messages of blocked site.Further, the patient felt fine as the blood glucose was not high and went for supplemental shots.However, the patient was unwell, tired, felt sick, threw up badly, hurting everywhere, chest was hurting, had to empty bladder, was severely dehydrated, low sodium level, troubled breathing, extremity pain, cramps, increased thirst.Therefore, the patient went to hospital on (b)(6) 2024.During hospitalization, the patient received intravenous fluids and manual shots.Also, the patient had to change the site four times due to blocked sites.Currently, the patient's blood glucose level was 99 mg/dl.At the time of this report, the patient was not released from the hospital.No further information was available.
 
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Brand Name
QUICK SET PARADIGM
Type of Device
UNO QUICK-SET 60/6 SC1 MECA
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key18786156
MDR Text Key336285473
Report Number3003442380-2024-00162
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 02/27/2024
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 Lot NumberUNKNOWN
Initial Date Manufacturer Received 02/19/2024
Initial Date FDA Received02/27/2024
Patient Sequence Number1
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