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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCU-CHEK ® INSIGHT FLEX SUBCUTANEOUS INFUSION SET

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ACCU-CHEK ® INSIGHT FLEX SUBCUTANEOUS INFUSION SET Back to Search Results
Lot Number ASKU
Device Problem Fluid Leak (1250)
Patient Problem Hyperglycemia (1905)
Event Date 10/09/2021
Event Type  malfunction  
Manufacturer Narrative
The event occurred outside of the united states. While this product is not sold in the united states, it is like or similar to a product marketed in the united states.
 
Event Description
It was reported that the infusion set was leaking at the headset and around the connector area, leading to elevated blood glucose levels.
 
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Brand NameACCU-CHEK ® INSIGHT FLEX
Type of DeviceSUBCUTANEOUS INFUSION SET
MDR Report Key12623842
MDR Text Key276148613
Report Number3011393376-2021-03172
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberASKU
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 10/13/2021 Patient Sequence Number: 1
Treatment
UNKNOWN INSULIN
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