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	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reporter's device and lancets were requested for investigation and replacement product was sent to the reporter.The product has not been received at this time.The investigation is ongoing.
Event or Problem Description
The initial reporter stated there was an issue with a coaguchek softclix lancet device.The reporter stated that a lancet was properly seated in the device, but the needle protruded past the end cap of the device.The reporter noted that the lancet needle appeared longer than other lancets in the box.The reporter inserted a new lancet and the needle did not protrude past the end cap of the device.
Additional Manufacturer Narrative
The coaguchek softclix lancet device and a package of 19 unused coagu-chek softclix lancets were returned for investigation.The reported failure on protruding lancets could not be confirmed during investigation.The customer lancing device was tested with test lancets (lot u21a8) and some of the customer lancets into a rubber at all different pricking depth settings, for each attempt needle was correctly retracted, ejected and produced a puncture hole.Furthermore, no lancet was sticking out of the end cap.The lancing device was disassembled for investigation, but no abnormal attribute was found which could verify the customer allegation.The lancing device works in accordance with specifications.Some of the received customer lancets were investigated with a microscope, but no abnormalities could be observed in terms of the customer allegations.

• Brand Name: COAGUCHEK SOFTCLIX
• Common Device Name: BLOOD LANCET
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): BALDA MEDICAL GMBH & CO. KG; bergkichener str. 228; bad oeynhausen 32549 ; GM 32549
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21634929
• Report Number: 1823260-2025-00773
• Device Sequence Number: 7480542
• Product Code: FMK
• UDI-Device Identifier: 07613336173046
• UDI-Public: 07613336173046
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: Health Professional
• Device Catalogue Number: 07313462001
• Device Lot Number: BBH146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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