MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. FREESTYLE LANCET; LANCETS

Catalog Number 98682-03

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

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 03/13/2015

Event Type  Injury  

Event Description

Customer reported experiencing pain and an infection on his finger after using an adc lancing device and lancet.Customer reported self-treating by applying betadine (antiseptic) to his finger and taking brufen (ibruprofen) orally.Customer self-presented to a local hospital where he was reportedly treated with fusidine (topical antibiotic), brufen, and an unspecified antibiotic.No diabetic diagnosis or treatment was rendered.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.Note: the date of event is unknown.Additionally, the device manufacturer date for the reported lancet is unknown.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE LANCET
• Type of Device: LANCETS
• Manufacturer (Section D): ABBOTT DIABETES CARE INC.; 1360 south loop road; alameda CA 94502 700
• Manufacturer Contact: meg manager ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 4673242
• MDR Text Key: 5608006
• Report Number: 2954323-2015-00199
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Reporter Country Code: PO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2015

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: 98682-03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 04/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention