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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 5235875
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Event or Problem Description
(b)(4).Event occurred in (b)(6).The tubing of the infusion set detached at quick release.Reportedly, it was observed that the insulin came out of the tubing about 8-10 hours after the set was changed.No further information available.
 
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Brand Name
MIO¿
Common Device Name
INSET II 46/6 PCC PINK
MDR Report Key8193635
Report Number3003442380-2018-00157
Device Sequence Number2141996
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? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Expiration Date04/01/2021
Device Lot Number5235875
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/26/2018
Initial Report FDA Received Date12/24/2018
Patient Sequence Number1
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