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

Catalog Number	05360145001
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lancet protrudes beyond the end cap of the device.
Additional Manufacturer Narrative
Section d: the suspect medical device was updated on this supplemental report to reflect the acc-chek fastclix lancets.Section g1: manufacturer information section was added/corrected on this report.New information was obtained on 18-feb-2026.The user reported that the fastclix device was dropped on the ground and that the lancet not retracting occured after the device was dropped.

• 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: natalie catton ; 9115 hague road; na; indianapolis, IN 46250-0457
• MDR Report Key: 24345297
• Report Number: 3011393376-2026-00122
• Device Sequence Number: 9912138
• Product Code: QRL
• UDI-Device Identifier: 00365702288102
• UDI-Public: 00365702288102
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K220608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 05360145001
• Device Lot Number: WPM053A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2024
• 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: 88 YR
• Patient Sex: Male
• Patient Weight: 71 KG