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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 5231134
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 issue and experienced high blood glucose level of 527 mg/dl and self-treated with a bolus.Subsequently, the patient went to the emergency with high blood glucose level between 422-477 mg/dl with high ketones level.The patient stayed in emergency for few hours and the patient left emergency, the blood glucose level was 420 mg/dl.The healthcare professional assessed ketone level as dangerous/life threatening.The infusion set was in use for one and half day.The patient received insulin drip as corrective treatment and the issue was resolved.The patient was hospitalized 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 Key8270038
Report Number3003442380-2019-00289
Device Sequence Number11250891
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
Is this a Product Problem Report? No
Operator of Device No Information
Device Expiration Date04/01/2021
Device Lot Number5231134
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/21/2018
Initial Report FDA Received Date01/23/2019
Patient Sequence Number1
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