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	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was alleged that a lancet was protruding past the end cap of a coaguchek xs softclix device.The customer was accidentally stuck by a lancet protruding past the end cap of the coaguchek xs softclix device.The customer did not require treatment.The customer believed the lancet was seated properly, but could not confirm this as the lancet had already been replaced.The customer was advised on how to prime and fire the device.The lancet no longer protruded past the end cap.
Additional Manufacturer Narrative
The customer's device was requested for investigation and a replacement product was sent to the customer.The investigation is ongoing.Section e3: occupation is patient/consumer.
Additional Manufacturer Narrative
No product was returned by the customer.As the product lot number is not available, no further investigations could be performed.A review of complaints did not identify any nonconformances related to the customer's allegation.

• 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: 20409495
• Report Number: 1823260-2024-02933
• Device Sequence Number: 9070159
• Product Code: FMK
• UDI-Device Identifier: 07613336173046
• UDI-Public: 07613336173046
• Combination Product (Y/N): Y
• Initial Reporter State: AR
• 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): 12/13/2024

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: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 12/13/2024
• 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