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

Catalog Number	08120242001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged there was an issue with a coaguchek xs softclix lancet device.The softclix device had a needle protruding through the dial cap.The customer confirmed the lancet was placed into the device properly until it clicked into place.
Additional Manufacturer Narrative
The customer's device was requested for investigation and replacement product was sent to the customer.The product has not yet been received at this time.If the product or additional relevant information is received in the future, a follow-up report will be submitted.Section e3: occupation is patient/consumer.
Additional Manufacturer Narrative
No product was returned for investigation, so further investigation was not possible.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18837977
• Report Number: 1823260-2024-00652
• Device Sequence Number: 7181505
• Product Code: FMK
• UDI-Device Identifier: 00365702702165
• UDI-Public: 00365702702165
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 05/20/2024

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: BBI036
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2022
• 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: Female