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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 5136942
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
(b)(4).Event occurred in the united states.The patient had experienced an issue where she was taken to the hospital due to being unresponsive in diabetic ketoacidosis.When they arrived at the hospital the medical team discovered that she had a bent cannula and was taken off the pump to be treated.Reportedly, the blood glucose was near 600 mg/dl.The patient received some unspecified fluids and insulin which resolved the issue.The infusion set was used for less than one day.The patient was admitted for five 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 Key8517471
Report Number3003442380-2019-01246
Device Sequence Number1611972
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 Number5136942
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/01/2017
Initial Report FDA Received Date04/16/2019
Patient Sequence Number1
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