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

Catalog Number	07313462001
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We were unable to determine the g1 manufacturer as the coaguchek softclix lancet lot number and expiration date were not provided.The consumer's material was requested for investigation on 20-feb-2025.The investigation is ongoing.
Event or Problem Description
We received an allegation that a properly seated coaguchek xs softclix lancet protrudes from the correctly positioned end cap when the correct lancet is used on the coaguchek xs softclix device.
Additional Manufacturer Narrative
Sections d4 and g1 were updated.On 21-may-2025, one coagu-chek xs softclix lancing device was received for investigation without the lancets.The customer lancing device was tested with test lancets lot number u21a8, into the rubber at all pricking depth settings.The results were that for each attempt, the needle was correctly retracted, ejected, and produced a puncture hole.In addition, no lancet was sticking out of the end cap.The lancing device was disassembled for investigation, and no abnormal attribute was found.The investigation did not identify a product problem.The lancing device works within specifications.

• 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
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21607766
• Report Number: 1823260-2025-00745
• Device Sequence Number: 8867785
• Product Code: FMK
• UDI-Device Identifier: 07613336173046
• UDI-Public: 07613336173046
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 06/16/2025

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: BBJ035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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