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

Lot Number 5309844

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation (2443)

Event Date 12/06/2020

Event Type  Injury  

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

It was reported that the patient experienced an allergic reaction while using the infusion set.On (b)(6) 2020, the patient had a skin inflammation with an abscess on the site where the cannula was inserted.The patient went to the dermatologist due to this issue.During the visit, the patient was prescribed with diprogenta® antibiotic and after using it the pain decreased.

• Brand Name: ACCU-CHEK FLEXLINK 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): 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 Key: 11057850
• MDR Text Key: 223207315
• Report Number: 3011393376-2020-04608
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/01/2022
• Device Lot Number: 5309844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR