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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSET¿II; INSET II 60/6 PINK
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INSET¿II; INSET II 60/6 PINK Back to Search Results
Lot Number 5133384
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 (b)(6).The patient reported that when she woke up, she noted high blood glucose level greater than or equal to 250mg/dl and noticed that the tubing had detached from the infusion set.No further information available.
 
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Brand Name
INSET¿II
Common Device Name
INSET II 60/6 PINK
MDR Report Key8468003
Report Number3003442380-2019-00734
Device Sequence Number16624357
Product Code FPA
UDI-Device Identifier05705244007635
UDI-Public05705244007635
Combination Product (Y/N)N
PMA/510(K) Number
K032854
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 Date01/01/2019
Device Lot Number5133384
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/28/2017
Initial Report FDA Received Date03/31/2019
Patient Sequence Number1
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