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

Lot Number 5258967

Device Problem Insufficient Information (3190)

Patient Problem Reaction, Injection Site (2442)

Event Date 10/13/2019

Event Type  Injury  

Manufacturer Narrative

Product is no longer available to be returned.

Event Description

It was reported that the patient experienced abscesses at the puncture site of the infusion set several times.On one occasion, she immediately scheduled an appointment with her primary hcp after noticing the abscess.The customer received a small surgical outpatient procedure on the abscess at her primary hcp office and was prescribed oral antibiotics.

• 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 Key: 9654749
• MDR Text Key: 180565394
• Report Number: 3011393376-2020-00412
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2020
• Device Lot Number: 5258967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 111