MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE, ABBOTT, SENSOR SENSOR.; SENSOR, GLUCOSE, INVASIVE

Model Number	71525-01
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Freestyle libre glucose monitoring system: the monitor box does not clearly distinguish between a 10 day or a 14 day reader.The pharmacy attached a 14 day reader label/prescription label to the box which does not clearly indicate whether it is a 10 or 14 day reader.Subsequently the pharmacy issued a 14 day sensor, however the readers do not read ten-day freestyle libre glucose monitoring system: the monitor box that comes with the monitor and it does not clearly distinguish between a 10 day and a 14 day reader.The pharmacy attached a 14 day reader label/prescription label to the box which does not clearly indicate whether it is a 10 or 14 gauge reader.Subsequently the pharmacy issued a 14 day sensor; however the monitors are not compatible inversely with 10 to 14 day readers.The reader must be compatible with the same sensor.A ten day reader must have a 10 day sensor.Even though the pharmacy put the incorrect label on the box, if the consumer does not know which is a ten day box and which is a 14 day box they cannot check the accuracy of the pharmacy's work.Having an elderly patient/family member who is very stressed from having to stick their fingers and more painful as they have aged.Combine this with other medical issues and it creates a very unsettled patient and household.If labeling is not clearly understandable how can the patient, family, provider, pharmacy be expected to verify that the box/packaging matches the necessary prescription? dose or amount: 1 topical skin with device attached, route: applied to a surface, usually the skin.Dates of use: (b)(6) 2018.Diagnosis or reason for use: diabetes.

• Brand Name: FREESTYLE LIBRE, ABBOTT, SENSOR SENSOR.
• Common Device Name: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): ABBOTT DIABETES CARE INC
• MDR Report Key: 8212758
• Report Number: MW5082778
• Device Sequence Number: 16571592
• Product Code: MDS
• UDI-Device Identifier: 00357599000219
• UDI-Public: 00357599000219
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2018
• Device Model Number: 71525-01
• Device Lot Number: 01Y695D
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 59