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U.S. Department of Health and Human Services

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

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ROCHE DIABETES CARE, INC. ACCU-CHEK ® INSIGHT FLEXLINK PLUS INFUSION SET; SUBCUTANEOUS INFUSION SET Back to Search Results
Lot Number ASKU
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2018
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 headsets do not stick enough.No adverse event reported.Requested return of the alleged device for evaluation.
 
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Brand Name
ACCU-CHEK ® INSIGHT 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 Key7230612
MDR Text Key98740217
Report Number3011393376-2018-00449
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 company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 02/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2018
Is the Reporter a Health Professional? No
Date Manufacturer Received02/07/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
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