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

Model Number	SAFE-T-PRO PLUS
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's lancets were requested for investigation and replacement product was sent to the customer.The occupation is patient/consumer.
Event or Problem Description
It was reported that a patient received an order of accu-chek safe-t-pro lancets and they were contaminated with mold.There was green and brown mold on the inside of the packaging and on the package insert.
Additional Manufacturer Narrative
One bag with 5 unused lancet devices were returned for investigation.The contamination with mold could be confirmed during the investigation.The affected lot number was packaged in (b)(6) 2021 and the batch record shows no record of any problems related to the device.The production process was reviewed and no abnormalities could be observed.The root cause of the contamination could not be identified.All bagged products are 100% visually checked.It is highly unlikely the issue occurred during the packaging process.The issue is consistent with contamination occurring either at customer site or at a third party.The investigation could not identify a product problem.The cause of the event could not be determined.
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: 13424495
• Report Number: 1823260-2022-00275
• Device Sequence Number: 19831545
• 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 Expiration Date: 03/31/2025
• Device Model Number: SAFE-T-PRO PLUS
• Device Catalogue Number: 03450074001
• Device Lot Number: 41821035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 03/22/2022; 10/16/2025
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 04/14/2022; 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