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	02/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's device was requested for investigation and replacement product was sent to the customer.
Event or Problem Description
It was reported that there was an issue with a coaguchek xs sofclix lancing device.The customer noted that the lancing device will no longer stick their finger and the lancet would not retract.The device will prime and fire the lancet.The lancet needle will stick out of the end cap after firing.The end cap was correctly installed.There was no allegation of an accidental fingerstick due to the exposed needle.The customer removed the unused needle and manually stuck their finger to get a sample.
Additional Manufacturer Narrative
The customer's lancing device was returned for investigation.The lancing device was tested with test lancets (lot u21a8) at 11 different pricking depth settings, for each attempt needle was correctly retracted, ejected, and produced a puncture hole.The lancing device could be primed and released without any problems and works in accordance with specifications.The lancing device was disassembled for investigation, but no abnormalities could be observed which could verify the customer's allegation.A review of complaint data was performed with a specific focus on the lot number of the lancing device.No increased cumulation of the alleged failure was identified for the affected production interval.

• 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: 16528542
• Report Number: 1823260-2023-00767
• Device Sequence Number: 5297666
• 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): 05/30/2023

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: Health Professional
• Device Catalogue Number: 07313462001
• Device Lot Number: BAU106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 05/30/2023
• 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