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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 06541810001
Device Problem Leak/Splash (1354)
Patient Problem Hypoglycemia (1912)
Event Date 12/24/2017
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 the self-adhesive plaster of the infusion set cannula gets wet every time she inserts the cannula with the insertion device. No adverse event reported. Requested return of the alleged device for evaluation.
 
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Brand NameACCU-CHEK ® FLEXLINK PLUS INFUSION SET
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
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key7150652
MDR Text Key95926217
Report Number3011393376-2017-06826
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeSP
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 02/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number06541810001
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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