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	03/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lancet device and lancets were requested for investigation and a replacement product was sent to the customer.Medwatch field.The occupation is patient/consumer.
Event or Problem Description
It was reported that a patient had an issue with a coaguchek xs softclix lancet device.The customer reported that the cap would not go onto the device.The device and the lancet within the device were reported to be seated in the correct position.When attempting to attach the cap to the device, the cap reportedly would not on the device.The lancet was protruding from the end cap prior to firing the lancet with the device.No accidental fingersticks were reported.
Additional Manufacturer Narrative
The lancing device was provided for investigation.The issue alleged by the customer could not be reproduced.The device was tested with test lancets (lot u21a8) at 11 different pricking depth settings.For each attempt, the lancet 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 cap could also be put on without any problems.The lancing device was disassembled and no abnormalities were observed.Upon review of complaint data, no increased cumulation of the alleged failure was identified for the affected production interval.Medwatch fields d4, d9, g1, h3, and h4 have been updated.

• 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; na; bad oeynhausen 32549 ; GM 32549
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16726416
• Report Number: 1823260-2023-01226
• Device Sequence Number: 7190440
• Product Code: FMK
• UDI-Device Identifier: 07613336173046
• UDI-Public: 07613336173046
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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: BBG110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• 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