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

Catalog Number	11893238160
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Impaired Healing (2378)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lancet tip broke off and was embedded in the puncture site on five occasions.The customer was able to remove the lancet tip from three puncture holes and believes that the lancet broke off on two more puncture sites as well.The customer did not receive any medical attention or treatment.
Additional Manufacturer Narrative
Correction - the manufacturing site name was updated in section g1.Section h4: the year is the only known part of manufacture date.We have defaulted to the first of the year.
Additional Manufacturer Narrative
This supplemental mdr is being submitted as a part of a retrospective review and remediation effort based on errors that occurred in the submission of mdrs for incorrect manufacturer name and/or address.A non-conformance report (ncr) ¿ (b)(4) to implement corrective actions was opened on january 29, 2025.Device performance and/or risk profile are not impacted.

• 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): BALDA MEDICAL GMBH & CO. KG; bergkichener str. 228; asku; bad oeynhausen GA 32549 ; GM 32549
• Manufacturer Contact: john krug ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 17668945
• Report Number: 3011393376-2023-01994
• Device Sequence Number: 7068095
• Product Code: FMK
• UDI-Device Identifier: 00075537009710
• UDI-Public: 00075537009710
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 07/22/2025

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: 11893238160
• Device Lot Number: BBI199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 10/05/2023; 07/22/2025
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 10/10/2023; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female