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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; INSET II 60/6 PCC PINK
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MIO¿; INSET II 60/6 PCC PINK Back to Search Results
Lot Number UNKNOWN
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's father reported that the patient was having issues with infusion set as she experienced a bent cannula due to which she had high blood glucose level (over 600 mg/dl) and strep throat.On (b)(6) 2019, she was admitted to the hospital with blood glucose level over 600 mg/dl and diabetic ketoacidosis (high ketone levels).During hospitalization, she received intravenous medication (drug name unknown).The patient's site location was at her leg or buttock and the infusion had been in use for one day.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 60/6 PCC PINK
MDR Report Key9472077
Report Number3003442380-2019-01966
Device Sequence Number11427807
Product Code FPA
UDI-Device Identifier05705244007697
UDI-Public05705244007697
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 Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/20/2019
Initial Report FDA Received Date12/16/2019
Patient Sequence Number1
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