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	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lancet device was discarded.Occupation was lay user/patient.
Event or Problem Description
The customer alleged the needle came out of the safe-t-pro plus lancet device.The customer attempted to remove the sterility cap and depth dial when the needle came out of the lancet device.The customer did not twist the sterility cap when the lancet came out of the device but had pulled it straight off.There was no accidental fingerstick with the safe-t pro plus lancet.
Additional Manufacturer Narrative
The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.Complaints regarding this allegation and the specific lot number involved were reviewed and showed no increase for the affected production interval.
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: 12353418
• Report Number: 1823260-2021-02428
• Device Sequence Number: 4633609
• Product Code: FMK
• UDI-Device Identifier: 00075537257890
• UDI-Public: 00075537257890
• 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 Expiration Date: 11/30/2024
• Device Model Number: SAFE-T-PRO PLUS
• Device Catalogue Number: 03450074001
• Device Lot Number: 41821005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/22/2021; 10/16/2025
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 10/14/2021; 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