MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE OPTIUM NEO H; BLOOD GLUCOSE MONITORING SYSTEM

Model Number 71181-70

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

Patient Problem Loss of consciousness (2418)

Event Date 01/03/2024

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing 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 delivery delay with a replacement adc device was reported.The replacement device was issued due to an error code 6 on the adc device.Due to delivery delay; customer was unable to test.The customer experienced a loss of consciousness and paramedics were called.The customer received unspecified treatment by a healthcare professional due to being unable to self-treat.There was no report of death or permanent impairment associated with this event.

Event Description

A delivery delay with a replacement adc device was reported.The replacement device was issued due to an error code 6 on the adc device.Due to delivery delay; customer was unable to test.The customer experienced a loss of consciousness and paramedics were called.The customer received unspecified treatment by a healthcare professional due to being unable to self-treat.There was no report of death or permanent impairment associated with this event.

Manufacturer Narrative

Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.The most probable root causes associated with this failure mode are disconnected, faulty or damaged components or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.At this time product has not yet been returned and a valid serial number has not been provided.An extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history review) for the freestyle optium neo h were reviewed and the dhrs showed the freestyle optium neo h passed all tests prior to release.Clinical data was reviewed and confirmed that precision strips continue to be safe, effective, and perform as intended in the field.Stability data for precision strips was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and precision strips, no trends were identified that would indicate any product related issues.If the product is returned, a physical investigation will be performed and a follow up report will be submitted.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE OPTIUM NEO H
• Type of Device: BLOOD GLUCOSE MONITORING 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: 18564087
• MDR Text Key: 333483346
• Report Number: 2954323-2024-03063
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K153330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71181-70
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2017
• 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