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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO; UNO INSET II 80/6 SC1 GREY MCAN
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MIO; UNO INSET II 80/6 SC1 GREY MCAN Back to Search Results
Model Number MMT-965A600
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2021, it was reported that the patient experienced high blood glucose levels.Consequently, on (b)(6) 2021 at 10:00 am, the patient was taken to the hospital with blood glucose level of more than 33 mmol/l and the patient experienced diabetic ketoacidosis due to a bent cannula.Reportedly, the bent cannula was noticed after removal of the infusion set.The patient received some unspecified drug intravenously (drug name unknown) as corrective treatment and stayed there overnight.Currently, the patient's blood glucose level was still more than 33 mmol/l.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 Name
MIO
Common Device Name
UNO INSET II 80/6 SC1 GREY MCAN
MDR Report Key12559258
Report Number3003442380-2021-00522
Device Sequence Number10994017
Product Code FPA
UDI-Device Identifier05705244020399
UDI-Public05705244020399
Combination Product (Y/N)Y
PMA/510(K) Number
K160648
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/01/2021
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
Operator of Device No Information
Device Expiration Date03/01/2023
Device Model NumberMMT-965A600
Device Lot Number5313463
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/20/2021
Initial Report FDA Received Date10/01/2021
Patient Sequence Number1
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