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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
Catalog Number 00048011811
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2021
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 self-adhesive of the infusion set was not sticking well enough. This occurred with multiple headsets from the same lot.
 
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Brand NameACCU-CHEK ® INSIGHT FLEX
Type of DeviceSUBCUTANEOUS INFUSION SET
MDR Report Key12453027
MDR Text Key270801623
Report Number3011393376-2021-02808
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,Followup
Report Date 10/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00048011811
Device Lot Number1328113
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/01/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Invalid Data

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