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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSET¿; INSET I 60/9 GREY
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INSET¿; INSET I 60/9 GREY Back to Search Results
Lot Number 5150069
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 faced kinked cannula issue.Reportedly the blood glucose level of the patient was 846 mg/dl and had experienced diabetic ketoacidosis 1+ levels.The patient self-treated with the bolus.Subsequently, the patient received insulin drip and dextrose 5% in normal saline as corrective treatment.The issue was resolved, as the blood glucose level now was reported to be 190 mg/dl.The patient was admitted for two days and there was no permanent damage to the patient.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
INSET¿
Common Device Name
INSET I 60/9 GREY
MDR Report Key8538449
Report Number3003442380-2019-01292
Device Sequence Number13531371
Product Code FPA
UDI-Device Identifier05705244006881
UDI-Public05705244006881
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 Number5150069
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/01/2017
Initial Report FDA Received Date04/23/2019
Patient Sequence Number1
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