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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 5136638
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 united states.The patient's mother reported that the infusion set's cannula was bent.Reportedly, the patient's blood glucose was 662 mg/dl and experienced diabetic ketoacidosis (ketone level was 7.2 mmol/l).The patient self-treated with a corrective bolus.Subsequently, the patient was admitted in the hospital, where insulin drip was given as a corrective treatment which resolved the issue.The patient was hospitalized 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 60/6 GREY
MDR Report Key8538623
Report Number3003442380-2019-01346
Device Sequence Number2458523
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 Lot Number5136638
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/15/2017
Initial Report FDA Received Date04/23/2019
Patient Sequence Number1
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