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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 Hypoglycemia (1912)
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 had detached/broken at the site connector. The patient's blood glucose level was 14 mg/dl. The patient replaced the infusion set and resumed insulin 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 Key12364053
MDR Text Key268036988
Report Number3003442380-2021-00398
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 Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000281
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
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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