MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK SOFTCLIX; BLOOD LANCET

Catalog Number	07313462001
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e1: occupation is patient/consumer.Section g1, zip code is not known.The lancet device and lancets were requested for investigation.
Event or Problem Description
The initial reporter complained of an issue with a coaguchek softclix lancet device.A new lancet was inserted into the device, and the needle protruded from the end cap.The lancet was reinserted, and the needle no longer protruded from the end cap.When the lancet was primed, the lancet protruded from the end cap.
Additional Manufacturer Narrative
The lancet device with no lancets was received for investigation.Sections d4, lot number, and d9 were updated.Section g1, manufacturing site was updated.Section h4 was updated.Section h4: the year is the only known part of manufacture date.We have defaulted to the first of the year.The customer's lancet device was tested with test lancets (lot u21a8) at all different depth settings.For each attempt, the needle correctly produced a puncture hole, retracted, and was ejected.The customer's allegation was not reproduced at the investigation site.No lancet was sticking out of the end cap.The lancet device was disassembled for investigation, and no abnormalities were observed.The lancet device operated within specification.The investigation did not identify a product problem.

• Brand Name: COAGUCHEK SOFTCLIX
• Common Device Name: BLOOD LANCET
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ASKU; asku; asku; asku
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22642857
• Report Number: 1823260-2025-02301
• Device Sequence Number: 8609745
• Product Code: FMK
• UDI-Device Identifier: 07613336173046
• UDI-Public: 07613336173046
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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: 07313462001
• Device Lot Number: BBH146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2021
• 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