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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 Detachment of Device or Device Component (2907)
Patient Problem Hyperglycemia (1905)
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 site connector thrice. At the time of the event, her blood glucose level was 400 mg/dl and the infusion set had been used for three days. Further, they tried to treat this issue with multiple daily injection. 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 Key12881280
MDR Text Key281313824
Report Number3003442380-2021-00764
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 11/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1000282
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received11/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided

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