MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS SC LANCING DEVICE KIT

Catalog Number	08120242001
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's device has been requested for investigation.The investigation is ongoing.
Event or Problem Description
The customer alleged there was an issue with a coaguchek xs softclix lancet device.The customer stated that the softclix device would not fire.The customer was able to insert a needle and put the cap on the softclix device.The customer was also able to move the cap to different depth settings.The customer was able to prime the softclix device and it sounded like it fired.The customer then alleged that the needle could be seen coming out of the end of the device.The customer ejected the needle from the softclix device.The device was working properly after this.The customer put the needle back into the device and it appeared to be properly seated.The customer was able to put the cap on the device and was able to adjust the settings, but alleged that the lancet needle was still extending past the cap.
Additional Manufacturer Narrative
The softclix lancing device was received for investigation with 10 unused lancets.The alleged failures "unable to get the device to fire" and "exposed lancet while properly seated in softclix device" could not be confirmed during the investigation.The customer sample was tested into a rubber mat with test lancets (accu-chek softclix lancets; lot u21a8) and all received lancets at all different pricking depth settings, for each attempt needles were correctly retracted, ejected, and produced a puncture hole.The lancing device could be activated and triggered without any problems and the lancets were not exposed after seated in the lancing device.The lancing device was disassembled for investigation, but no abnormal attribute was found which could verify the customer's allegation.The lancing device works in accordance with specifications.As no customer-used lancets were received, no further investigation is possible.The investigation could not identify a product problem.Medwatch fields d1, d2, d4, and h3 have been updated.

• Brand Name: COAGUCHEK XS SC LANCING DEVICE KIT
• Common Device Name: LANCING DEVICE
• 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 46250-0457
• MDR Report Key: 18790769
• Report Number: 1823260-2024-00563
• Device Sequence Number: 8296998
• Product Code: FMK
• UDI-Device Identifier: 00365702702165
• UDI-Public: 00365702702165
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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): 04/01/2024

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: 08120242001
• Device Lot Number: BBE032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2018
• 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
• Patient Sex: Unknown