MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. SOFTCLIX ® LANCETS

Model Number 11893238160

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

Patient Problem Skin Infection (4544)

Event Date 12/29/2021

Event Type  Injury  

Manufacturer Narrative

The year is the only known part of manufacture date.We have defaulted to the first of the year.

Event Description

It was reported that the patient experienced an infection on her finger in which she alleged it was caused by puncturing her finger with the lancet device.The patient experienced pain and red streaks on her infected finger.The tip of her finger became numb.The patient made multiple trips to the doctor because the finger was not healing.The patient received two antibiotics and antifungal cream that didn't resolve the issue.The patient was eventually prescribed bactrim, which cleared up the infection.The infection persisted for approximately two months before healing.

Manufacturer Narrative

Correction to section d, reported product.

• Brand Name: SOFTCLIX ® LANCETS
• Type of Device: LANCET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): FACET TECHNOLOGIES LLC; 3900 north commerce drive; na; atlanta GA 30344
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 14240970
• MDR Text Key: 290370189
• Report Number: 3011393376-2022-01278
• Device Sequence Number: 1
• Product Code: FMK
• UDI-Device Identifier: 00075537009710
• UDI-Public: 00075537009710
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K214022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 11893238160
• Device Catalogue Number: 11893238160
• Device Lot Number: BBF580
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2019
• Is the Device Single Use?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female