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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 the infusion set cannula was kinked.Reportedly, his blood glucose level was over 700 mg/dl, experienced diabetic ketoacidosis which he self-treated with a correction bolus.Subsequently, he was admitted to the hospital and was given insulin drip and lantus (insulin glargine) which resolved the issue.The infusion set was used for one day.He was hospitalized for two days and there was no permanent damage to him.Moreover, this was the second time that he was admitted into the hospital due to diabetic ketoacidosis that week.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
T:90¿ INFUSION SET
Common Device Name
INSET II 60/9 GREY
MDR Report Key8542813
Report Number3003442380-2019-01297
Device Sequence Number1744121
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 05/10/2017
Initial Report FDA Received Date04/24/2019
Patient Sequence Number1
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