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

Catalog Number	05181186001
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
Type of Reportable Event	Malfunction
Additional 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.Section h4: 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 lancet protrudes beyond the end cap of the device.

• Brand Name: SOFTCLIX ® LANCET DEVICE
• Common Device Name: LANCET DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): BALDA MEDICAL GMBH & CO. KG; bergkichener str. 228; na; bad oeynhausen 32549 ; GM 32549
• Manufacturer Contact: brian frazier ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 20400216
• Report Number: 3011393376-2024-02081
• Device Sequence Number: 2996400
• Product Code: FMK
• UDI-Device Identifier: 04015630082209
• UDI-Public: 04015630082209
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 05181186001
• Device Lot Number: BBJ160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female