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	01/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation is patient/consumer.The lancet device was requested for investigation.It had been advised that the device will be replaced.
Event or Problem Description
We received an allegation of a lancet protruding from the endcap of a coaguchek xs softclix lancet device.It had been reported that the lancet was set up correctly but it protruded more than once.During the call, the patient mentioned that the needle was not currently protruded.No accidental finger stick occured.The patient's therapeutic range is 2.0-3.0 inr.
Additional Manufacturer Narrative
Sections d9, g3, h2 and h3 were updated.The coaguchek xs softclix lancing device (lot number bbg171) was provided for investigation.The reported failure on protruding lancets could not be confirmed during 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.Furthermore, a review on complaint data was performed with specific focus on the reported lot number bbg171.No increased cumulation of the alleged failure was identified for the affected production interval.The patient did not return the lancets for investigation.As no product was returned, a specific root cause could not be determined.All product batches of the roche diabetes care gmbh are controlled with regard to the quality requirements of the product prior to delivery.If all quality requirements are fulfilled in the quality control process, goods are released and ready for delivery.All non-conforming products are handled in accordance to iso 13485.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 16430025
• Report Number: 1823260-2023-00562
• Device Sequence Number: 20161377
• 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): 05/11/2023

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: ASKU
• 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: 01/27/2023
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANTICOAGULANT MEDICATION
• Patient Sex: Male