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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
Model Number MMT-399A
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, the patient's father reported that his daughter experienced nausea, vomiting, abdominal pain and difficulty in breathing. At the time of the incident, her blood glucose level was 350 mg/dl and she was using an insulin pen. Further, she was admitted to the hospital with blood glucose level of 700 and diabetic ketoacidosis. Moreover, she was taking shots and was hospitalized for seven days. Currently, (at the time of the call), her blood glucose level was 233 mg/dl. Upon visual inspection of the returned used device (two sets), it was found that the soft cannula was kinked (at the tip and the middle). 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 60/6 SC1 MECA
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key11830274
MDR Text Key250816651
Report Number3003442380-2021-00248
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 Received05/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-399A
Device Lot Number5334677
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2021
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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