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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 5285553
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 mother reported that her daughter had high blood glucose level of 500 mg/dl (at the time of incident), so they went to the health care professional and were subsequently sent to the hospital.Moreover, the patient was stable now, and the mother of the patient and the health care professional identified that the bent cannula was the reason of high blood glucose level.It was stated that the infusion set was changed twice.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 Key9374572
Report Number3003442380-2019-01932
Device Sequence Number11529804
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 Date06/01/2022
Device Lot Number5285553
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/31/2019
Initial Report FDA Received Date11/26/2019
Patient Sequence Number1
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