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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO; UNO INSET II 60/6 SC1 PINK MCAN

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MIO; UNO INSET II 60/6 SC1 PINK MCAN Back to Search Results
Model Number MMT-923A600
Device Problem Infusion or Flow Problem (2964)
Patient Problem Hypoglycemia (1912)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2021, the patient's mother reported that the patient received insulin flow block.The blood glucose level was reported as 7.4 mmol/l and the infusion set had been used for few hours.Reportedly, the site of insertion was the patient's arm.No further information available.
 
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Brand Name
MIO
Type of Device
UNO INSET II 60/6 SC1 PINK MCAN
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key12679515
MDR Text Key277839915
Report Number3003442380-2021-00622
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244020245
UDI-Public05705244020245
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
Report Date 10/22/2021
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 Operator No Information
Device Expiration Date04/01/2024
Device Model NumberMMT-923A600
Device Lot Number5350758
Initial Date Manufacturer Received 10/14/2021
Initial Date FDA Received10/22/2021
Type of Device Usage N
Patient Sequence Number1
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