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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: T:90¿ INFUSION SET; INSET II 60/9 GREY
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T:90¿ INFUSION SET; INSET II 60/9 GREY Back to Search Results
Lot Number UNKNOWN
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 reported that she was not receiving insulin due to a bent cannula that led to high blood glucose and diabetic ketoacidosis.Her blood glucose at the time of the incident was above 500 mg/dl and the infusion set had been in use for 1 day.She was given a metered dose inhaler in an attempt to resolve the issue.No activity was performed prior to hospitalization.The patient received intravenous and mdi as a part of treatment and this resolved the issue.She was hospitalized for 4 days.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices ofinsertion 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
T:90¿ INFUSION SET
Common Device Name
INSET II 60/9 GREY
MDR Report Key8543384
Report Number3003442380-2019-01310
Device Sequence Number2431296
Product Code FPA
UDI-Device Identifier05705244004450
UDI-Public05705244004450
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 NumberUNKNOWN
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/09/2018
Initial Report FDA Received Date04/24/2019
Patient Sequence Number1
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