MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK ® FASTCLIX LANCETS

Catalog Number	05360145001
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lancet broke off in the patient's finger.The patient was able to remove the lancet fragment by himself and did not require treatment by a medical professional.He received an x-ray which showed pieces of the lancet remained in his finger.
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) ¿ 16847 to implement corrective actions was opened on january 29, 2025.Device performance and/or risk profile are not impacted.

• Brand Name: ACCU-CHEK ® FASTCLIX LANCETS
• Common Device Name: LANCET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): WEIDMANN MEDICAL TECHNOLOGY AG; industriestrasse 96; na; bad ragaz 7310 ; SZ 7310
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 9864944
• Report Number: 3011393376-2020-01099
• Device Sequence Number: 526408
• Product Code: FMK
• UDI-Device Identifier: 00365702288102
• UDI-Public: 00365702288102
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 07/23/2025

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 Expiration Date: 12/31/2022
• Device Catalogue Number: 05360145001
• Device Lot Number: WPG100B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 04/20/2020; 07/22/2025
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 05/06/2020; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2019
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 125 KG