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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® FLEXLINK PLUS INFUSION SET; SUBCUTANEOUS INFUSION SET
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ROCHE DIABETES CARE, INC. ACCU-CHEK ® FLEXLINK PLUS INFUSION SET; SUBCUTANEOUS INFUSION SET Back to Search Results
Catalog Number 00048011511
Device Problems Failure To Adhere Or Bond (1031); Leak/Splash (1354)
Patient Problem Hyperglycemia (1905)
Event Date 02/06/2018
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
Caller alleges adhesive is not sticking which has resulted in a leak.Caller reported that four cannulas from this lot have not stuck properly to his skin; was able to self-treat.No adverse event reported.Requested return of the alleged device for evaluation.
 
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Brand Name
ACCU-CHEK ® FLEXLINK PLUS 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)
GERRESHEIMER REGENSBURG GMBH
hirtenstrasse 50
na
pfreimd 92536
GM   92536
Manufacturer Contact
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key7333711
MDR Text Key102211854
Report Number3011393376-2018-01115
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 company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number00048011511
Device Lot Number1211120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Treatment
NOVORAPID
Patient Age45 YR
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