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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90 INSET II 2-PACK 60/9 GREY TCAP

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AUTOSOFT 90 INSET II 2-PACK 60/9 GREY TCAP Back to Search Results
Model Number 1000282
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 as his infusion set fell off during use due to excessive sweating during a funeral. Therefore, the patient experienced high blood glucose level due to this issue which they tried to treat with a bolus via pump. On (b)(6) 2022, the patient went to the emergency room and was subsequently hospitalized due to high blood glucose level. His highest blood glucose level was 630 mg/dl. Moreover, the infusion had been used for few hours. Further, the patient was transferred to the intensive care unit. During hospitalization, he received fluids of saline, insulin, and unspecified medication (drug name unknown) as corrective treatment which resolved the issue. On the day of this report, the patient was still in the hospital and had no permanent damage. No further information available.
 
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Brand NameAUTOSOFT 90
Type of DeviceINSET II 2-PACK 60/9 GREY TCAP
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key15049316
MDR Text Key296130916
Report Number3003442380-2022-00874
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244014572
UDI-Public05705244014572
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 07/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1000282
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received07/12/2022
Was Device Evaluated by Manufacturer? No Answer Provided

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