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

Catalog Number 04509781001

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

Patient Problem Unspecified Infection (1930)

Event Date 12/17/2017

Event Type  Injury  

Manufacturer Narrative

It was unknown if the initial reporter sent report to the fda.

Event Description

The customer reported that she received an infection in her finger while using the multclix device.The customer stated that she did not always advance to the next lancet in the drum, and used the same lancet over many times.The customer stated that on (b)(6) 2017 she noticed that her finger was red, swollen, and ached really bad.The customer did not do anything to treat the finger.On (b)(6) 2017 the condition of the finger remained the same so the customer went to a medical clinic.The customer was diagnosed with an infection in her finger and prescribed antibiotics.The name of the antibiotic was not provided.The lot number was not provided.Return of the suspect device was requested for evaluation.

• Brand Name: ACCU-CHEK ® MULTICLIX LANCETS
• Type of Device: LANCET
• Manufacturer (Section D): ROCHE DIABETES CARE, INC.; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): WEIDMANN MEDICAL TECHNOLOGY; industriestrasse 96; na; bad ragaz 7310 ; SZ 7310
• Manufacturer Contact: greg smith ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3175212484
• MDR Report Key: 7285337
• MDR Text Key: 100531635
• Report Number: 3011393376-2018-00856
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

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: 04509781001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 05/29/2018
• Supplement Dates FDA Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CIPROFLOXACIN
• Patient Outcome(s): Required Intervention