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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT

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AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT Back to Search Results
Model Number 1002819
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. The patient reported that he faced an adhesive issue on (b)(6) 2021, as the infusion set patch not sticky/did not adhere to body upon insertion due to which he experienced high blood glucose level. Therefore, the patient tried to treat it with a bolus via the pump. This issue occurred with three infusion sets and the patient had not resumed the pump yet. On the same day ((b)(6) 2021), the patient went to the emergency room with blood glucose level of 1091 mg/dl. After staying for 7 hours in the emergency room, he was subsequently admitted to the intensive care unit. During hospitalization, the patient was administered fluids of saline, insulin, and an unknown medication intravenously (drug name unknown) as corrective treatment which resolved the issue. On (b)(6) 2021, the patient was released from the hospital with no permanent damage. No further information available.
 
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Brand NameAUTOSOFT 90
Type of DeviceUNO INSET II 60/9 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key12459308
MDR Text Key270995646
Report Number3003442380-2021-00459
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K032854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1002819
Device Lot Number5349763
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2021
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

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