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

Catalog Number	07313462001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a retraction issue with a coaguchek softclix lancet device.On troubleshooting, the reporter noticed that the lancet was sticking out past the end cap of the softclix device after priming.The reporter stated that the lancet was seated properly at the time the lancet would not retract and that the device was not fired because the lancet was already sticking out.The reporter stated that the lancet was not used and no one was accidentally stuck.The reporter inserted a new lancet and was able to prime and fire the device without the lancet protruding.The reporter was able to perform a test.
Additional Manufacturer Narrative
The device was requested for investigation and a replacement product was sent to the customer.Medwatch field e3.Occupation - the occupation is patient/consumer.
Additional Manufacturer Narrative
The device was not received for investigation.

• Brand Name: COAGUCHEK SOFTCLIX
• Common Device Name: BLOOD LANCET
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17337446
• Report Number: 1823260-2023-02287
• Device Sequence Number: 20665570
• Product Code: FMK
• UDI-Device Identifier: 07613336173046
• UDI-Public: 07613336173046
• 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
• Report Date (Section B): 11/21/2023

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: BB0110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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