MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC LIBRELINK; DATA MANAGEMENT SYSTEM

Model Number 71733-01

Device Problems Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)

Patient Problems Fatigue (1849); Headache (1880); Hyperglycemia (1905)

Event Date 04/19/2023

Event Type  Injury  

Manufacturer Narrative

The product is currently undergoing investigation.A follow-up report will be submitted once additional information is obtained.The device mfg date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A "scan error" message was reported with the adc device and customer was unable to obtain readings.As a result, customer experienced difficulty walking and a headache and was unable to self-treat, requiring health care provider unspecified treatment for a diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Per smartphone compatibility information with use of application, alcatel device has not been tested for compatibility at the time of investigation.The compatibility guide states that abbott diabetes care has not assessed compatibility on phone/operating systems other than those listed.Attempted to replicate the user¿s complaint using samsung galaxy a52 (android 13, 2.8.4.9335) and successfully received glucose readings.No issues were identified with the freestyle librelink app.Therefore, issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A "scan error" message was reported with the adc device in use with samsung galaxy a52, os version 13, app version 2.8.4.9335 and customer was unable to obtain readings.As a result, customer experienced difficulty walking and a headache and was unable to self-treat, requiring health care provider unspecified treatment for a diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.

• Brand Name: LIBRELINK
• Type of Device: DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 17052389
• MDR Text Key: 316467309
• Report Number: 2954323-2023-23363
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P160030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71733-01
• Device Catalogue Number: 71733-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention