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

Catalog Number 05864666160

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

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

The year is the only known part of manufacture date.We have defaulted to the first of the year.

Event Description

It was reported that a roche employee received an accidental finger stick during training.The employee accidentally fired the fastclix device into her finger.At 11:15 am the employee went to the (b)(6) center and was given a tetanus shot.The employee was advised to go to the hospital within 24 hours to have a blood test performed.Requested return of suspect device and replacement was sent.

• Brand Name: ACCU-CHEK ® FASTCLIX
• Type of Device: LANCET DEVICE
• 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: 7702354
• MDR Text Key: 114421971
• Report Number: 3011393376-2018-03034
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 05864666160
• Device Lot Number: GDD080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Weight: 89