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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 5207874
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.It was reported that the patient went into diabetic ketoacidosis due to a kinked cannula.The patient was given multiple daily injection.Subsequently, the patient was hospitalized where the patient received multiple daily injections, anti-nausea medicine and unknown medication through intravenous route, which resolved the issue.The patient stayed in the hospital for seven days.Furthermore, it was reported that similar instance took place in the past where the patient may have stayed 2-3 days in the hospital due to her kinked cannula.The same treatment was received as in the one reported.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 Key8535045
Report Number3003442380-2019-01214
Device Sequence Number2458360
Product Code FPA
UDI-Device Identifier05705244014305
UDI-Public05705244014305
Combination Product (Y/N)N
PMA/510(K) Number
K162812
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 Expiration Date10/01/2020
Device Lot Number5207874
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/18/2018
Initial Report FDA Received Date04/22/2019
Patient Sequence Number1
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