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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® INSIGHT FLEX SUBCUTANEOUS INFUSION SET

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ROCHE DIABETES CARE, INC. ACCU-CHEK ® INSIGHT FLEX SUBCUTANEOUS INFUSION SET Back to Search Results
Lot Number 1364130
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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. Product no longer available for return.
 
Event Description
It was reported that the self-adhesive of the infusion set was not sticking well enough. This issue occurred with two infusion sets from the same package.
 
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Brand NameACCU-CHEK ® INSIGHT FLEX
Type of DeviceSUBCUTANEOUS INFUSION SET
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
GERRESHEIMER REGENSBURG GMBH
hirtenstrasse 50
na
pfreimd 92536
GM 92536
Manufacturer Contact
john krug
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key14999980
MDR Text Key295781972
Report Number3011393376-2022-02045
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number1364130
Was Device Available for Evaluation? No
Date Manufacturer Received07/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/30/2022
Is the Device Single Use? Yes
Type of Device Usage Invalid Data

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