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

Model Number	11893238160
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	12/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The year is the only known part of manufacture date.We have defaulted to the first of the year.
Event or Problem 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.
Additional Manufacturer Narrative
Correction to section d, reported product.

• Brand Name: SOFTCLIX ® LANCETS
• Common Device Name: 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
• Report Number: 3011393376-2022-01278
• Device Sequence Number: 4887149
• Product Code: FMK
• UDI-Device Identifier: 00075537009710
• UDI-Public: 00075537009710
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K214022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/15/2022
• Supplement Date Received by Manufacturer: 06/29/2022; 03/01/2023
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 06/29/2022; 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female