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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 Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states. It was reported that from (b)(6) 2022 to (b)(6) 2022, the patient's infusion set's tubing detached/broken at the site connector and this issue occurred before insertion. Moreover, they replaced the infusion set and insulin was resumed 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
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lejre, 4320
MDR Report Key13897050
MDR Text Key287916420
Report Number3003442380-2022-00442
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
Reporter Occupation
Type of Report Initial
Report Date 03/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1002817
Device Lot Number5354686
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided

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