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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90; UNO INSET II 60/6 BLUE TCAP 10PK INT
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AUTOSOFT 90; UNO INSET II 60/6 BLUE TCAP 10PK INT Back to Search Results
Lot Number UNKNOWN
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 the patient faced a bent cannula due to which he experienced high blood glucose level.Therefore, they tried to treat it with fluids/insulin as he thought that he had a heart attack, but six months ago on (b)(6) 2023 (approximately), the patient first went to the emergency room and was subsequently hospitalized due to high blood glucose level.His highest blood glucose level was 600 mg/dl.Moreover, the infusion had been used for one day and the site location was his abdomen.During hospitalization, the patient received fluids of saline, insulin, unspecified medication (drug name unknown) intravenously and sugar water (to help keeping his blood glucose level falling fast) as corrective treatment which resolved the issue.On (b)(6) 2023 (approximately), the patient was released from the hospital with no permanent damage.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 was available.
 
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Brand Name
AUTOSOFT 90
Type of Device
UNO INSET II 60/6 BLUE TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key18453047
MDR Text Key332262455
Report Number3003442380-2024-00109
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K032854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 01/05/2024
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
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 12/28/2023
Initial Date FDA Received01/05/2024
Patient Sequence Number1
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