MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LANCING DEVICE

Model Number 70473-03

Device Problem Misfire (2532)

Patient Problem Local Reaction (2035)

Event Date 04/17/2018

Event Type  Injury  

Manufacturer Narrative

The customer's products have been requested for investigation.A follow-up report will be filed once the product is returned or additional information is obtained.The date of manufacture is unknown.The date listed is the date when abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A nurse reported that on (b)(6) 2018 she accidentally ¿poked her finger with the patient¿s lancet¿.She further reported she cleaned her finger, disinfected it and then went to a hospital.At the hospital, customer had labs drawn for unspecified analysis.On (b)(6) 2018 she received a hepatitis vaccination and was advised to return in three and six months for follow-up.Attempts to gather additional information have thus far been unsuccessful.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE LANCING DEVICE
• Type of Device: LANCING DEVICE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: devin dirstine ; 1360 south loop road; alameda, CA 94502-7001 ; 5108644391
• MDR Report Key: 7559147
• MDR Text Key: 109736554
• Report Number: 2954323-2018-04140
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70473-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention