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

Catalog Number	05360145001
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This case, with patient identifier (b)(6), is related to case with patient identifier (b)(6).
Event or Problem Description
The caller reported that he opened a new box of accu-chek fastclix lancet drums; upon removing the lancets from the box, one of the lancet drums broke into pieces and the lancet came out.The customer received an accidental lancet stick on the palm of the hand.No medical treatment was required.
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: 10931379
• Report Number: 3011393376-2020-04332
• Device Sequence Number: 4282729
• Product Code: FMK
• UDI-Device Identifier: 00365702288102
• UDI-Public: 00365702288102
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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 Catalogue Number: 05360145001
• Device Lot Number: WPG062A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 02/11/2021; 07/22/2025
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 02/12/2021; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 93 KG