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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 04631293001
Device Problem Loss of or Failure to Bond (1068)
Patient Problems Hyperglycemia (1905); Reaction, Injection Site (2442)
Event Date 02/02/2020
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, which resulted in elevated blood glucose levels.Caller reported that there was some redness and irritation at the injection site.
 
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Brand Name
ACCU-CHEK FLEXLINK INFUSION SET
Type of Device
SUBCUTANEOUS 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
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key9708460
MDR Text Key179824073
Report Number3011393376-2020-00591
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date04/01/2020
Device Catalogue Number04631293001
Device Lot Number5228022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2020
Is the Reporter a Health Professional? No
Date Manufacturer Received05/08/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
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