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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INSET¿; INSET I 60/6 GREY
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INSET¿; INSET I 60/6 GREY Back to Search Results
Lot Number 5150090
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 kinked cannula issue.Reportedly, her blood glucose level was 1000 mg/dl and she experienced diabetic ketoacidosis.She attempted to change the site and self-treated with correction boluses with the pump and 10 units of multiple daily injection.She also gave 15 units of boluses by the pump, on the day of her hospitalization.Subsequently, she was hospitalized and received insulin and intravenous drip as corrective treatment which resolved the issue.She was admitted for four 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 60/6 GREY
MDR Report Key8538418
Report Number3003442380-2019-01289
Device Sequence Number11370494
Product Code FPA
UDI-Device Identifier05705244006874
UDI-Public05705244006874
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 Date06/01/2019
Device Lot Number5150090
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/15/2017
Initial Report FDA Received Date04/22/2019
Patient Sequence Number1
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