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	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation - the occupation is lay user/patient.
Event or Problem Description
The customer complained that a coaguchek softclix lancet device did not fully retract and extends beyond the end cap.The lancets were inserted correctly into the device.The customer stated that some lancets in the box appeared to be longer than normal and were sticking out of the device.There was no allegation of an adverse event.The suspect product was requested to be returned for investigation.
Additional Manufacturer Narrative
Fourteen unused lancets were returned for investigation.The reported failure that some of the lancets are longer than normal and the longer ones stick out of the device, could not be reproduced during the investigation.All lancets were tested with a test accu-chek softclix lancing device (lot baz034) at 11 different pricking depth settings, for each attempt needle was correctly retracted, ejected and produced a puncture hole, and no needle tip protruded outside the end cap.The lancing device could be primed and released without any problems and works in accordance with specifications.All lancets were investigated with a stereo microscope.The investigation showed that one lancet is a slightly shorter than the other lancets.In addition, all needle tips were compared against each other and all needles have the same length.

• 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: 7938375
• Report Number: 1823260-2018-03430
• Device Sequence Number: 930450
• Product Code: FMK
• UDI-Device Identifier: 00365702702165
• UDI-Public: 00365702702165
• 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): 11/12/2018

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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1