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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 60/9 GREY TCAP
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AUTOSOFT 90; INSET II 60/9 GREY TCAP Back to Search Results
Lot Number UNKNOWN
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 faced bent cannula issues that led to an increase in patient's blood glucose level.Highest blood glucose level was reported to be 600 mg/dl that was treated with a correction bolus.Subsequently, the patient was hospitalized and received intravenous insulin drip, which resolved the issue.Reportedly, the patient used the infusion set for two days.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
AUTOSOFT 90
Common Device Name
INSET II 60/9 GREY TCAP
MDR Report Key8338227
Report Number3003442380-2019-00522
Device Sequence Number16678581
Product Code FPA
UDI-Device Identifier05705244014367
UDI-Public05705244014367
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? Yes
Operator of Device No Information
Device Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/05/2018
Initial Report FDA Received Date02/14/2019
Patient Sequence Number1
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