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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
Catalog Number 06541801001
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. No material will be returned (discarded).
 
Event Description
It was reported that the self-adhesive of the infusion set was not sticking well enough.
 
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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 Key13073960
MDR Text Key282923293
Report Number3011393376-2021-03989
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUK
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 12/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number06541801001
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received12/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Invalid Data

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