MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK SOFTCLIX; LANCET DEVICE

Catalog Number	04908368001
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated there was an issue with the coaguchek softclix lancing device.The customer indicated that the lancet was protruding past the end cap of the lancing device before priming.The customer removed the cap of the device and confirmed that the lancet was seated properly.The customer re-installed the cap, but the issue persisted.The lancet was still protruding past the end cap of the device.
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The softclix lancing device without lancets was received for investigation.The reported failure on protruding lancets could not be confirmed during the investigation.The lancing device was tested with test lancets (lot u21a8) into a rubber mat 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 allegation.As the customer lancets are not available, no further investigation is possible.

• Brand Name: COAGUCHEK SOFTCLIX
• Common Device Name: LANCET 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: 18969090
• Report Number: 1823260-2024-00887
• Device Sequence Number: 17680903
• Product Code: FMK
• UDI-Device Identifier: 07613336173046
• UDI-Public: 07613336173046
• 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): 05/03/2024

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: 04908368001
• Device Lot Number: BBA062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2014
• 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