MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK FASTCLIX; LANCET DEVICE

Model Number	07531567160
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The year is the only known part of manufacture date.We have defaulted to the first of the year.
Event or Problem Description
It was reported that the lancet protrudes beyond the end cap of the device.

• Brand Name: ACCU-CHEK FASTCLIX
• Common Device Name: LANCET DEVICE
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10704561
• Report Number: 3011393376-2020-03781
• Device Sequence Number: 3569895
• Product Code: FMK
• UDI-Device Identifier: 00365702702219
• UDI-Public: 00365702702219
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/22/2020

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: 07531567160
• Device Catalogue Number: 07531567160
• Device Lot Number: 33319233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 12/22/2020
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 104