MAUDE Adverse Event Report: ROCHE DIAGNOSTICS SAFE-T-PRO PLUS; LANCET

Catalog Number	03448622001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's accu-chek safe-t-pro plus lancets were requested for investigation.The investigation is ongoing.
Event or Problem Description
We received an allegation about missing sterility cover/tip from 25 accu-chek safe-t-pro plus lancets.No allegation of injuries occurred.
Additional Manufacturer Narrative
The customer's accu-chek safe-t-pro plus lancets were provided for investigation on 30-jan-2024.The visual inspection confirmed the issue of the sterility cap missing from the lancets and the lancing devices were not triggered / the release buttons were not activated.Therefore, the accu-chek safe-t pro lancing devices were forwarded to the supplier for further investigation.The check of (b)(4) retention samples from the relevant production lot number 41823050 at the supplier showed no deviation.The verification of the returned products showed all lancing devices were missing caps as alleged.The review of the manufacturing process and manufacturing records at the supplier showed no areas where the lancet caps were twisted or pulled and there was no record of any problems or other issues related to this failure.There is no possibility that the issue occurred in the manufacturing process.The investigation did not identify a product problem.The cause was consistent with the issue occurring outside roche control.
Additional Manufacturer Narrative
G1 contact office-manufacturing site was updated.

• Brand Name: SAFE-T-PRO PLUS
• Common Device Name: LANCET
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): FACET TECHNOLOGIES LLC; 112 town park drive suite 300; kennesaw GA 30144
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18659421
• Report Number: 1823260-2024-00354
• Device Sequence Number: 17940682
• Product Code: FMK
• UDI-Device Identifier: 00075537257890
• UDI-Public: 00075537257890
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2025

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: Health Professional
• Device Catalogue Number: 03448622001
• Device Lot Number: 41823050
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 04/10/2024; 10/16/2025
• Initial Report FDA Received Date: 02/07/2024
• Supplement Report FDA Received Date: 04/10/2024; 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown