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

Catalog Number	08120242001
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The occupation is lay user/patient.
Event or Problem Description
The patient stated that a lancet was protruding from the end cap of his coaguchek xs sc lancing device.The lancet was properly seated within the device.The end cap was also properly seated.The patient stated that the device was working fine until (b)(6) 2018.Nothing was broken off inside the lancet holder.The patient claims that the lancet was seated all the way down within the device, but was protruding from the end cap.No adverse events were alleged to have occurred.There were no injuries related to the protruding lancet.The patient's product was requested for investigation and replacement product was sent to the patient.
Additional Manufacturer Narrative
The patient lancets were returned for investigation.The reported failure on protruding lancets could not be confirmed during the investigation.The customer sample was tested with all received customer lancets at all different pricking depth settings, for each attempt the needle was correctly retracted, ejected, and produced a puncture hole.The lancing device was disassembled for investigation, but no abnormality which could explain the customer's allegation was found.The lancing device works in accordance with specifications.

• 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
• MDR Report Key: 7906800
• Report Number: 1823260-2018-03294
• Device Sequence Number: 1807160
• Product Code: FMK
• UDI-Device Identifier: 00365702702165
• UDI-Public: 365702702165
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

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: BBD039
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 09/10/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1