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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90 INSET II 2-PACK 60/6 GREY TCAP

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AUTOSOFT 90 INSET II 2-PACK 60/6 GREY TCAP Back to Search Results
Model Number 1000281
Device Problem Material Twisted/Bent (2981)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states it was reported that a (b)(6)-year-old male child patient faced a kinked cannula after more than three hours of insertion, due to which he experienced high blood glucose levels. To treat the issue, correction injection via multiple daily injection was administered. This issue occurred with five infusion sets between 01-aug-2021 and 31-aug-2021. Reportedly, for the first four events, his blood glucose level was in the range of 54-500 mg/dl (3. 0-27. 7 mmol/l). However, on (b)(6) 2021, his blood glucose level was over 500 mg/dl and the infusion set was used for three days. Moreover, he had high ketones, which were not dangerous/life threatening, as assessed by his health care professional. However, the patient was taken to the emergency room, where he received fluids of saline and insulin as corrective treatment which resolved the issue. He stayed in the emergency room for 4 to 5 hours. On the same day ((b)(6) 2021, he was released from the hospital with no permanent damage. Further, they replaced the infusion set and insulin was resumed successfully. 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 NameAUTOSOFT 90
Type of DeviceINSET II 2-PACK 60/6 GREY TCAP
Manufacturer Contact
aaholmvej 1-3
lejre, 4320
MDR Report Key12518272
MDR Text Key272867258
Report Number3003442380-2021-00499
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 09/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1000281
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage