MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK SOFTCLIX; LANCET DEVICE

Model Number	ACCU-CHEK 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 investigations are ongoing.The device was returned for investigation.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction events.The customer had a broken accu-chek softclix lancing device where the needle was protruding beyond the cap.The events involved a total of 1 patient.
Additional Manufacturer Narrative
The customer's lancing device was returned for investigation and the issue could not be reproduced or confirmed.The lancing device worked in accordance with specifications and had no damage.

• Brand Name: ACCU-CHEK SOFTCLIX
• Common Device Name: LANCET DEVICE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8273359
• Report Number: 1823260-2019-90001
• Device Sequence Number: 158659
• 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: ACCU-CHEK SOFTCLIX
• Device Lot Number: ASKU
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 04/11/2019
• Patient Sequence Number: 1