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

Catalog Number 00048011811

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2018

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 headset does not stick.Caller reported she uses a barrier film to make the plaster stick better but all 6 headsets fell off almost immediately after 2 minutes.Caller reported the issue also occurred with previous packages, but not to this extent as it only involved 1 or 2 cannulas.No adverse event reported.Requested return of the alleged product for evaluation.

• 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 Key: 7400438
• MDR Text Key: 104548211
• Report Number: 3011393376-2018-01493
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2019
• Device Catalogue Number: 00048011811
• Device Lot Number: 1211197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 05/28/2018
• Supplement Dates FDA Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 49 YR