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

Lot Number ASKU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

The event occurred outside of the united states while this product is not sold in the united states, it is like or similar to a product marketed in the united states.

Event Description

A sales representative received an accidental fingerstick while preparing an accu-chek fastlcix device at a pharmacy for a demonstration.The sales representative mistakenly picked up the pharmacy's accu-chek fastlcix device, instead of the demonstration device and accidentally punctured his finger.There was risk that the pharmacy device/lancet was used by a prior patient.The sales representative went to the doctor and got lab tests performed to analyze for any infection and was also prescribed unknown antibiotics.The lab results came back negative.

• Brand Name: ACCU-CHEK FASTCLIX LANCETS
• Type of Device: LANCET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): GERRESHEIMER REGENSBURG GMBH; hirtenstrasse 50; na; pfreimd 92536 ; GM 92536
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 11497221
• MDR Text Key: 240130710
• Report Number: 3011393376-2021-00765
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention