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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO¿; INSET II 46/6 PCC BLUE
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MIO¿; INSET II 46/6 PCC BLUE Back to Search Results
Lot Number UNKNOWN
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Hyperglycemia (1905)
Type of Reportable Event Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that tubing came out of clip at quick release connector while sleeping.The patient shot with pen and got the site on.The site was at the upper hip and the pump was on the same side in relation with the site.The infusion had been in use for one day.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.The patient was uncertain whether there was stress or pull on the tubing as the pump might fell out of pocket and was hanging off the bed.The patient was unsure whether the pump was dropped with the set connected to the patient's body.No further information available.
 
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Brand Name
MIO¿
Common Device Name
INSET II 46/6 PCC BLUE
MDR Report Key8494817
Report Number3003442380-2019-00999
Device Sequence Number13879139
Product Code FPA
UDI-Device Identifier05705244007314
UDI-Public05705244007314
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 Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/08/2018
Initial Report FDA Received Date04/09/2019
Patient Sequence Number1
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