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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 60/6 GREY TCAP
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AUTOSOFT 90; INSET II 60/6 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.It was reported that the patient experienced diabetic ketoacidosis and high blood glucose level (above 500 mg/dl), which she tried to self-treat with a bolus via pump.She had received high blood glucose alerts and her highest blood glucose level reported was above 533 mg/dl.Subsequently, she was hospitalized where she received insulin drip and unspecified medication via intravenous route, which resolved the issue.The patient had a bent cannula when the site was removed from her body.There was no permanent damage to the patient and the infusion had been in use for less than one day.She was hospitalized for two days and was able to resume insulin therapy, thereafter.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 60/6 GREY TCAP
MDR Report Key8682118
Report Number3003442380-2019-01533
Device Sequence Number19253822
Product Code FPA
UDI-Device Identifier05705244014305
UDI-Public05705244014305
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
Is this a Product Problem Report? No
Operator of Device No Information
Device Lot NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/15/2019
Initial Report FDA Received Date06/10/2019
Patient Sequence Number1
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