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

Model Number	SAFE-T-PRO
Medical Device Problem Code	Ejection Problem (4009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: occupation is lay user/patient.The lancets were requested for investigation.
Event or Problem Description
There was a complaint of having trouble getting enough blood with the accu-chek safe-t-pro plus lancet.The customer stated it does not feel like the lancet is going into his finger straight on but at an angle and therefore is not able to get enough blood.There was no allegation of any injuries.
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.
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): HTL - STREFA S.A.; adamowek 7; na; ozorkow (poland region) 95-03 5; PL 95-035
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12196606
• Report Number: 1823260-2021-02102
• Device Sequence Number: 19710148
• 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,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
• Device Catalogue Number: 03450074001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 06/28/2021; 10/16/2025
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/12/2021; 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown