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

Model Number	COAGUCHEK XS LANCING DEVICE
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation is lay user/patient.
Event or Problem Description
The customer complained that the accu-chek softclix lancet device came apart and was in pieces.The customer also stated a properly seated lancet protruded from the end cap of the device.The customer stated the yellow light stays on even after pressing the oval button to activate the lancing mechanism.The customer stated she was pressing the end cap onto the device and the lancet needle penetrated her skin.No medical treatment was required due to the accidental stick.There was no allegation that an adverse event occurred.The lot number and expiration date for the lancets was not provided.The lancets and lancet device were requested for investigation.
Additional Manufacturer Narrative
The reported failures of protruding lancets and that the lancing device had malfunctioned, could not be reproduced during investigation.The lancing device could be primed and released without any problems and works in accordance with specifications.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
• MDR Report Key: 7897820
• Report Number: 1823260-2018-03227
• Device Sequence Number: 1706807
• 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): 11/06/2018

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 Model Number: COAGUCHEK XS LANCING DEVICE
• Device Catalogue Number: 08120242001
• Device Lot Number: BAZ084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/04/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1