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

Model Number 71733-01

Device Problems Device Alarm System (1012); Application Program Problem (2880)

Patient Problems Bruise/Contusion (1754); Hypoglycemia (1912); Pain (1994); Loss of consciousness (2418)

Event Date 01/15/2024

Event Type  Injury  

Event Description

Abbott diabetes care received an mhra declaration which reported the following information: an alarm issue was reported with the adc application where the low/high glucose alarms did not sound.¿device failed to set off hypo alarm on mobile phone to which it was connected via bluetooth.¿ as a result, customer experienced ¿acute hypo, collapsed on floor, damaging ribs and front teeth.It is not known how long patient was unconscious (probably a few minutes).Husband/carer did not know extent of injuries, so [customer] was made comfortable; warm and ambulance called.Ambulance crew (ac) arrived 4 hours later, and first aid was administered and concluded that rib may have been broken and (customer)had vital signs checked.Ac advised to take strong pain killers and to report incident to general practitioner (gp) and dentist.Patient saw gp who advised to continue to take strong pain killers until pain subsided.Patient suffered discomfort in mouth.Patient was seen by dentist and x-rays showed no damage." the customer further reported that "subsequent recent investigation showed that alarms on phone had been turned off.Alarms were reset manually to on.However recently phone ios was updated by apple inc and update process had reset alarms to off and required manual intervention on software to switch alarms back on.This has now happened twice since original incident.¿ adc customer service attempted to contact the customer times to gain additional details regarding this event; however, all follow up attempts were unsuccessful.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Extended investigation is pending at this time.A follow up will be submitted once additional information is obtained.The device manufacturing date does not apply.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.

• Brand Name: FREESTYLE LIBRELINK
• Type of Device: DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda 94502 7001
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda 94502-7001 ; 5107495297
• MDR Report Key: 18980677
• MDR Text Key: 338625477
• Report Number: 2954323-2024-10024
• 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
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71733-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2024
• 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
• Patient Sex: Female