MAUDE Adverse Event Report: ROCHE DIABETES CARE, INC. ACCU-CHEK FASTCLIX LANCETS

Catalog Number	05360145001
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lancets were uncapped out of box.

• Brand Name: ACCU-CHEK FASTCLIX LANCETS
• Common Device Name: LANCET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9792215
• Report Number: 3011393376-2020-00827
• Device Sequence Number: 2373032
• Product Code: FMK
• UDI-Device Identifier: 00365702288102
• UDI-Public: 00365702288102
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/01/2020

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 05360145001
• Device Lot Number: WPH037A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 06/01/2020
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 93