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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 04631242001
Device Problem Failure To Adhere Or Bond (1031)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/16/2018
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 the cannulas of the last two boxes (same lot #) are a concern as the adhesive plaster detached, sometimes 2 to 3 times per day. Denied leak. No adverse event reported. Requested return of the alleged device for evaluation.
 
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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
greg smith
9115 hague road
na
indianapolis, IN 46250-0457
3175212484
MDR Report Key7651835
MDR Text Key112782592
Report Number3011393376-2018-02798
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeIT
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 08/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2019
Device Catalogue Number04631242001
Device Lot Number5201434
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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