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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 60/6 GREY TCAP
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AUTOSOFT 90; INSET II 60/6 GREY TCAP 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
(b)(4).Event occurred in the united states the patient faced bent cannula issues that caused high blood glucose level, reported to be more than 500 mg/dl.The patient went to the emergency room where the patient went through blood tests, received shots and unspecified medication through intravenous route.The patient stayed there for 12 hours and left the emergency room with blood glucose level at 300 mg/dl.Subsequently, the patient was admitted to the hospital.While in the hospital, the patient again went through blood tests, received shots and unspecified medication through intravenous route, which resolved the issue.There was no permanent damage to the patient.The patient did not notice any damage when the package was first opened.The patient stayed in the hospital for three days and used multiple daily injections since release from the hospital.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
AUTOSOFT 90
Common Device Name
INSET II 60/6 GREY TCAP
MDR Report Key8681564
Report Number3003442380-2019-01527
Device Sequence Number13885532
Product Code FPA
UDI-Device Identifier05705244014305
UDI-Public05705244014305
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 05/15/2019
Initial Report FDA Received Date06/10/2019
Patient Sequence Number1
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