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	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: occupation is patient/consumer.The lancet device and lancets were requested for investigation.
Event or Problem Description
There was an allegation of an issue with the coaguchek xs softclix lancet device.The customer alleged the lancet was protruding from the end cap after firing the device.The dial cap was properly seated at the time.The lancets lot number was 10521052 with an expiration date of 31-nov-2024.
Additional Manufacturer Narrative
The lancet device and lancets were received for investigation.Section h4: the year is the only known part of the manufacture date.We have defaulted to the first of the year.The customer's allegation could not be confirmed during the investigation.The customer's lancet device was tested with the customer's lancets at 11 different pricking depth settings and, for each attempt, the needle correctly produced a puncture hole, retracted, and ejected.The lancet device could be primed and released with no issues and worked according to specifications.The lancet device was disassembled and no abnormalities were observed.The lancets were investigated with a microscope and no abnormalities were observed.Complaints regarding this allegation and the specific lot number involved were reviewed and showed no increase for the affected production interval.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16610617
• Report Number: 1823260-2023-00954
• Device Sequence Number: 6067630
• 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): 04/10/2023

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: BBG172
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/10/2023
• 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: Female