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

Model Number	SAFE-T-PRO PLUS
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	08/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation is patient/consumer.The product was requested for investigation, however, the lancets were discarded.The customer could not provide the lot number for the lancets as the customer no longer has the box from this event.The customer is using a new box of safe-t-pro plus lancets and they are working properly.Since no product was returned, the cause of the event could not be determined.
Event or Problem Description
The initial reporter complained of an issue with a box of accu-chek safe-t-pro plus lancets.The date of event is an approximation.The reporter stated this occurred "several weeks ago." the customer stated the sterility cap of the lancets was very difficult to remove.When the customer finally got the sterility cap off, the needle came out with the cap.The customer stated the needle remained in the sterility cap but could not remember if the needle was completely covered/enclosed by the cap or if it stuck out.The customer was not injured by the needle that came out along with the cap.The customer was not sure if she was twisting the sterility cap or pulling the sterility cap when attempting to remove it.
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; na; kennesaw GA 30144
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12627922
• Report Number: 1823260-2021-02969
• Device Sequence Number: 4344860
• Product Code: FMK
• UDI-Device Identifier: 00365702702196
• UDI-Public: 00365702702196
• 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
• 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 Model Number: SAFE-T-PRO PLUS
• Device Catalogue Number: 03450074001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2021
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 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: Female