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U.S. Department of Health and Human Services

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

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ROCHE DIABETES CARE, INC. ACCU-CHEK ® FLEXLINK INFUSION SET SUBCUTANEOUS INFUSION SET Back to Search Results
Catalog Number 07333781001
Device Problem Loss of or Failure to Bond (1068)
Patient Problem Hyperglycemia (1905)
Event Date 05/08/2022
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 is not expected to be returned.
 
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 ® FLEXLINK INFUSION SET
Type of DeviceSUBCUTANEOUS INFUSION SET
Manufacturer (Section D)
ROCHE DIABETES CARE, INC.
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
UNOMEDICAL DEVICES S.A. DE C.V
avenida fomento industrial lot
parque industrial del norte
reynosa C.P. 8873
MX C.P. 88736
Manufacturer Contact
john krug
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key14368127
MDR Text Key291457568
Report Number3011393376-2022-01431
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeRS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number07333781001
Device Lot Number5344440
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2021
Is the Device Single Use? Yes
Type of Device Usage Invalid Data

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