MAUDE Adverse Event Report: BALDA MEDICAL GMBH & CO. KG 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	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation that a properly seated coaguchek xs softclix lancet protrudes from the correctly positioned end cap when the correct lancet is used on the coaguchek xs softclix device.
Additional Manufacturer Narrative
The coaguchek softclix lancets lot number and expiration date were not provided.The reporter's softclix device and lancets were requested for the investigation, however, the box of the softclix lancets is no longer available.A replacement for the softclix device and a sample pack of the softcix lancets were sent.The investigation is ongoing.
Additional Manufacturer Narrative
Section d4 was updated.The investigation is ongoing.
Additional Manufacturer Narrative
Sections d4 and d9 were updated.The coaguchek xs softclix lancing device was received for investigation.The lancing device was tested with test lancets into a rubber mat at 11 different pricking depth settings, for each attempted needle was correctly retracted, ejected, and produced a puncture hole.The lancing device could be primed and released without any problems and after inserting the lancet and installing the cap no needle was produced.The lancing device was disassembled for investigation and no abnormalities were observed.The investigation did not identify a product problem.

• Brand Name: COAGUCHEK SOFTCLIX
• Common Device Name: BLOOD LANCET
• Manufacturer (Section D): BALDA MEDICAL GMBH & CO. KG; bergkichener str. 228; bad oeynhausen IN 32549 ; GM 32549
• Manufacturer (Section G): ASKU; asku; asku; asku
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-ASKU
• MDR Report Key: 20609879
• Report Number: 1823260-2024-03193
• Device Sequence Number: 18119969
• Product Code: FMK
• UDI-Device Identifier: 07613336173046
• UDI-Public: 07613336173046
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 01/06/2025

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: BAY094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: 11/06/2024; 12/10/2024
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 12/03/2024; 01/06/2025
• 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