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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT

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AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT Back to Search Results
Model Number 1002817
Device Problem Loss of or Failure to Bond (1068)
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 since the beginning of (b)(6) 2022, the patient's infusion set fell off during use that led to high blood glucose levels which they tried to treat with multiple daily injections. Further, it was an ongoing issue of infusion sets falling off, and sometimes they fall within minutes of insertion. The infusion set had been used for about half a day. However, the patient had used other methods to assist adhesive in sticking to skin. Consequently, on (b)(6) 2022, he went to the emergency room with blood glucose level of 420 mg/dl, high ketones, and diabetic ketoacidosis. The health care professional assessed it as dangerous and life threatening. During hospitalization, he was administered fluids of saline, insulin, and some unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue. On (b)(6) 2022, he was released from the hospital with no permanent damage. Moreover, about two weeks ago ((b)(6) 2022), his infusion set fell off during use. The infusion set had been used for a maximum of one and a half day. They replaced the infusion set and resumed insulin successfully. No further information available.
 
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Brand NameAUTOSOFT 90
Type of DeviceUNO INSET II 60/6 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key14332580
MDR Text Key291285821
Report Number3003442380-2022-00600
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244018129
UDI-Public05705244018129
Combination Product (y/n)Y
PMA/PMN Number
K032854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 05/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1002817
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received04/14/2022
Was Device Evaluated by Manufacturer? No Answer Provided

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