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	02/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's lancet device was requested for investigation and a replacement product was sent to the customer.Section e3: occupation is patient/consumer.
Event or Problem Description
The customer reported an issue with a coaguchek xs softclix lancet device.The customer stated that the needle was protruding out of the softclix lancet device after poking their finger.The customer noted that the lancet was protruding past the cap of the device prior to the customer poking their finger as well.The customer confirmed that the lancet was seated properly in the device.The customer confirmed they were not harmed due to poking their finger with the protruding lancet.
Additional Manufacturer Narrative
No product was returned for investigation.A review of complaint data was performed with a focus on the stated lancing device lot number bbh146.The complaint data review shows no increased cumulation of the alleged failure in the affected production interval.
Additional Manufacturer Narrative
Medwatch fields d9 and h3 updated.The accu-chek softclix lancing device was received for investigation.The investigation confirmed the lancet was protruding past the cap before use.The test lancets could not be inserted properly in the customer's lancing device.The lancing device was disassembled and investigation with a microscope showed that the lancet holder was handicapped by a foreign object (tissue) causing the inserted lancets to be incorrectly fixed into the lancet holder, thereby causing the reported failure.The foreign object was removed and the lancing device worked per specifications.There were no other issues noted.The investigation determined the event was due to a handling error (foreign object in the lancet holder).The investigation did not identify a product problem.

• Brand Name: COAGUCHEK SOFTCLIX
• Common Device Name: BLOOD LANCET
• 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
• MDR Report Key: 18875084
• Report Number: 1823260-2024-00724
• Device Sequence Number: 7876312
• Product Code: FMK
• UDI-Device Identifier: 07613336173046
• UDI-Public: 07613336173046
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 06/13/2024

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: 07313462001
• Device Lot Number: BBH146
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 04/11/2024; 06/13/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 04/12/2024; 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2021
• 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