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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT 30 INSET 30 2-PACK 60/13 GREY TCAP

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AUTOSOFT 30 INSET 30 2-PACK 60/13 GREY TCAP Back to Search Results
Model Number 1000283
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. The patient's blood glucose level was 265 mg/dl, as the patient did not receive insulin. However, to treat this issue, the patient replaced the site and a correction injection via multiple daily injection was administered. Moreover, this event did not cause any injury. Further, they replaced the infusion set and insulin was resumed successfully. No further information available.
 
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Brand NameAUTOSOFT 30
Type of DeviceINSET 30 2-PACK 60/13 GREY TCAP
MDR Report Key12597368
MDR Text Key275389049
Report Number3003442380-2021-00553
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K061374
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 10/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1000283
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
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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