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

Catalog Number	08029016160
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an issue with an accu-chek safetpro plus lancing device.The user alleged that he would remove the protective cap of the lancing device by pulling it out with his teeth.The needle would then protrude past the end cap of the device.The user was not injured by the protruding lancet and did not receive medical treatment.
Additional Manufacturer Narrative
The user's lancing device was requested for investigation.
Additional Manufacturer Narrative
No product was received for investigation.A review of complaint data was performed with a focus on accu-chek safe-t-pro plus lancets with lot number 41821099.The complaint data review shows no increased cumulation of the alleged failure in the affected production interval.
Additional Manufacturer Narrative
G1 contact office-manufacturing site was updated.

• Brand Name: ACCU-CHEK 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; na; kennesaw GA 30144
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16269041
• Report Number: 1823260-2023-00283
• Device Sequence Number: 12363723
• Product Code: FMK
• UDI-Device Identifier: 00365702702141
• UDI-Public: 00365702702141
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Other
• 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: Lay User/Patient
• Device Catalogue Number: 08029016160
• Device Lot Number: 41821099
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 03/06/2023; 10/16/2025
• Initial Report FDA Received Date: 01/30/2023
• Supplement Report FDA Received Date: 03/17/2023; 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Male