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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 90 INSET II 2-PACK 60/6 GREY TCAP

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AUTOSOFT 90 INSET II 2-PACK 60/6 GREY TCAP Back to Search Results
Model Number 1000281
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 on (b)(6) 2021, the patient's infusion set's tubing detached/broken at the site connector. Moreover, they replaced the infusion set and insulin was resumed successfully. No further information available.
 
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Brand NameAUTOSOFT 90
Type of DeviceINSET II 2-PACK 60/6 GREY TCAP
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key12553254
MDR Text Key273994025
Report Number3003442380-2021-00515
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
Report Date 09/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000281
Device Lot Number5345497
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2021
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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