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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; INSET II 80/6 PCC GREY
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MIO¿; INSET II 80/6 PCC GREY Back to Search Results
Lot Number 5270477
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).It was reported that the patient experienced nausea, vomiting, abdominal pain, had difficulty in breathing and was tested positive for ketones.The patient also had high blood glucose level reported to be 28 mmol/l at the time of incident.On (b)(6) 2019, she was subsequently admitted to the hospital.When her infusion set was removed, it was found that there was a little curve in the cannula.The hospital told the patient that there were more issues than the slightly bent cannula.On (b)(6) 2019, she had computed tomography scan and was still in the hospital.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 80/6 PCC GREY
MDR Report Key8929257
Report Number3003442380-2019-01738
Device Sequence Number2207051
Product Code FPA
UDI-Device Identifier05705244007819
UDI-Public05705244007819
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 Date02/01/2022
Device Lot Number5270477
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/31/2019
Initial Report FDA Received Date08/26/2019
Patient Sequence Number1
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