MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK XS SC LANCING DEVICE KIT

Catalog Number	08120242001
Medical Device Problem Codes	Retraction Problem (1536); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The consumer's softclix device and lancets were requested for investigation.The investigation is ongoing.
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 consumer's softclix device and lancets were requested for the investigation, however, there is no product to return because the consumer had discarded the lancets.A review of complaint data was performed with a focus on lot numbers bbh146 and 10523147.The complaint data review showed no increased cumulation of the alleged failure in the affected production interval.All product batches at the manufacturer are controlled with regard to the quality requirements of the product prior to delivery.If all quality requirements are fulfilled in the quality control process, goods are released and ready for delivery.All non-conforming products are handled per iso 13485.The investigation did not identify a product problem.
Additional Manufacturer Narrative
Sections d1, d2a, d2b, d4, and g1 were updated.The type of investigation code, investigation findings code, investigation conclusion code, and component code were updated.The lancets were not received for investigation since the consumer discarded them.All product batches of roche diagnostics gmbh are controlled with regard to the quality requirements of the product prior to delivery.If all quality requirements are fulfilled in the quality control process, goods are released and ready for delivery.All non-conforming products are handled in accordance to iso 13485.The investigation did not identify a product problem.

• Brand Name: COAGUCHEK XS SC LANCING DEVICE KIT
• Common Device Name: LANCING 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
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18942043
• Report Number: 1823260-2024-00821
• Device Sequence Number: 8232112
• Product Code: FMK
• UDI-Device Identifier: 00365702702165
• UDI-Public: 00365702702165
• 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,Followup
• Report Date (Section B): 09/06/2024

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: 08120242001
• Device Lot Number: BBI036
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/05/2024; 08/14/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/25/2024; 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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