MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK SOFTCLIX; LANCET DEVICE

Model Number	COAGUCHEK SOFTCLIX
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation results are not yet determined.The follow up/corrective actions are not yet determined.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction event.The patient complained that after inserting a new lancet and placing the cap on, the needle protruded from the end of the lancing device past the cap.The events involved a total of 1 patients with the following: coaguchek softclix.The patients' ages ranged from (b)(6) to (b)(6) for two patients.The remaining patients' ages were requested, but were not provided.The patient's weight was requested, but not provided.There was one male.The patient's race was requested, but not provided.The patient's ethnicity was requested, but not provided.
Additional Manufacturer Narrative
The customer returned the coaguchek xs softclix lancing device without the lancets.The device was returned on (b)(6) 2019.The customer device was tested with test lancets.After inserting a lancet, it protruded outside the end cap and did not retract.The lancing device was disassembled for investigation and the spring arm of the lancet holder was deformed which caused the reported malfunction.This is usually caused by extensive use (significant usage marks were identified) or by a user error (pricking on a hard surface).

• Brand Name: COAGUCHEK SOFTCLIX
• Common Device Name: LANCET DEVICE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8286365
• Report Number: 1823260-2019-90057
• Device Sequence Number: 2141669
• Product Code: FMK
• UDI-Device Identifier: 00365702400108
• UDI-Public: 00365702400108
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: No
• Operator of Device: No Information
• Device Model Number: COAGUCHEK SOFTCLIX
• Device Lot Number: ASKU
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 04/11/2019
• Patient Sequence Number: 1