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	11/13/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer alleged there was an issue with the coaguchek xs softclix lancet device.The lancet was properly seated within the softclix device, but the lancet needle was protruding past the end cap of the device.The issue occurred after the device was primed.After firing the device, the lancet no longer protruded.
Additional Manufacturer Narrative
The lancing device was received for investigation, without lancets.The reported failure of protruding lancets could not be confirmed during the 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 within specifications.The lancing device was disassembled for investigation, but no abnormalities could be observed which could verify the customer's allegation.As the customer lancets are not available, no further investigation is possible.No increased cumulation of the alleged failure was identified for the affected production interval of the reported lot number.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: 18265359
• Report Number: 1823260-2023-03846
• Device Sequence Number: 11735008
• Product Code: FMK
• UDI-Device Identifier: 00365702702165
• UDI-Public: 00365702702165
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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): 02/28/2024

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: Lay User/Patient
• Device Catalogue Number: 08120242001
• Device Lot Number: BBI035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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