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

Model Number 75175-84

Device Problems Failure to Power Up (1476); Unable to Obtain Readings (1516)

Patient Problems Headache (1880); Hyperglycemia (1905)

Event Date 08/01/2022

Event Type  Injury  

Event Description

A customer reported a delivery issue associated with a replacement adc device.The customer initially reported that the adc device would not power on with button press or strip insertion.The customer indicated that due to the delivery issue, they did not have a device to monitor glucose and experienced headache.The customer reported they were hospitalized and received treatment of serum for hyperglycemia and also received unspecified antibiotics and diuretics.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

At this time product has not yet been returned.An extended investigation has been conducted under investigation report ivr-pqe-800, which involved a manufacturing review (including device history records (dhrs), previous complaint and corrective and preventive action (capa) investigations conducted for blank screen issues, process failure mode effects analyses (pfmeas), design controls, and design failure mode effects analyses (dfmeas), risk management reports, risk evaluations, and label copy.The investigation addresses the customer¿s complaint in this case and did not identify any trend or potential root cause that would indicate that the product is not meeting specification.The device mfg date is unknown.The date entered in device manufacture date is the date abbott diabetes care became aware of the event.The exact date of incident is unknown.The date entered in date of event is per the customer's report of "first week of august." all pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE PRECISION NEO
• 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: 15844484
• MDR Text Key: 304115043
• Report Number: 2954323-2022-42776
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K140371
• 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: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 75175-84
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2022
• 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