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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; INSET II 46/6 PCC PINK
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MIO¿; INSET II 46/6 PCC PINK Back to Search Results
Lot Number 5242792
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 the united states.The patient faced bent cannula issue on the first day of infusion set use during insertion due to which she experienced diabetic ketoacidosis and high blood glucose level reported to be 450 mg/dl at the time of incident.The patient tried to self-treat it with the pump and changed the infusion set.Subsequently, the patient was admitted to the hospital due to diabetic ketoacidosis, where she received unspecified medication through intravenous route.The patient reconnected to the pump in the hospital.The site location was patient's stomach.The patient stayed in the hospital for two days and was still there with blood glucose level at 450 mg/dl at the time of this report.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
INSET II 46/6 PCC PINK
MDR Report Key8657000
Report Number3003442380-2019-01505
Device Sequence Number19401766
Product Code FPA
UDI-Device Identifier05705244007376
UDI-Public05705244007376
Combination Product (Y/N)N
PMA/510(K) Number
K160648
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
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 Date06/01/2021
Device Lot Number5242792
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/27/2018
Initial Report FDA Received Date05/31/2019
Patient Sequence Number1
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