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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 30 UNO INSET 30 60/13 GREY TCAP 10PK INT

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AUTOSOFT 30 UNO INSET 30 60/13 GREY TCAP 10PK INT Back to Search Results
Model Number 1002825
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 the patient faced an issue with the infusion set as it would not stay in place/adhesive due to which he experienced high blood glucose level. Therefore, they tried to treat it with multiple daily injections, but on (b)(6) 2022, the patient went to the emergency room and was subsequently hospitalized due to high blood glucose level. The infusion had been used for about half a day. The patient's highest blood glucose level was 420 mg/dl and had high ketone levels. During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) as corrective treatment which resolved the issue. On (b)(6) 2022, the patient was released from the hospital with no permanent damage. Moreover, ongoing since (b)(6) 2022 about two weeks ago ((b)(6) 2022) the infusion set fell off during use. The patient used skin tac and other methods to assist adhesive in sticking to skin. He still had same issued and sometime, it occurs within minutes of insertion. His blood glucose level was around 350 mg/dl at the time of the event. The infusion had been used for one and a half days. Further, they replaced the infusion set and insulin was resumed successfully. The patient had gone back to multiple daily injections because the infusion set issues were causing his blood glucose level to rise. He already had episodes of diabetic ketoacidosis resulting in hospitalization. No further information available.
 
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Brand NameAUTOSOFT 30
Type of DeviceUNO INSET 30 60/13 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key14332589
MDR Text Key291228098
Report Number3003442380-2022-00614
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244018365
UDI-Public05705244018365
Combination Product (y/n)Y
PMA/PMN Number
K061374
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 Number1002825
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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