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

Model Number 75175-83

Device Problem Battery Problem (2885)

Patient Problems Vomiting (2144); Dizziness (2194); Loss of consciousness (2418); Shaking/Tremors (2515)

Event Date 02/22/2022

Event Type  Injury  

Manufacturer Narrative

At this time product has not yet been returned.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 records) for the freestyle precision neo meter were reviewed and the dhrs showed the freestyle precision neo meter passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller reported customer was unable to test using his adc device as the meter "sometimes doesn't turn on" due to unspecified battery issue.Caller further reported that due to this issue the customer became dizzy and fell, and experienced vomiting, fever, tremors, and a loss of consciousness.Customer had contact with a healthcare professional at home, who provided primperan (antiemetic and gut motility stimulator), diclofenaco (nsaid), antigen test (covid-19), and capillary blood glucose test (unspecified result).The caller did not report of further treatment.There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the reader and no issues were observed.The reader powered on with button depression.No battery life/fast draining was observed.No low battery icon/message was observed.The meter not shutting off was not observed.Unk/unspecified battery/ no power issue was not observed.Therefore, the issue is not confirmed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A caller reported customer was unable to test using his adc device as the meter "sometimes doesn't turn on" due to unspecified battery issue.Caller further reported that due to this issue the customer became dizzy and fell, and experienced vomiting, fever, tremors, and a loss of consciousness.Customer had contact with a healthcare professional at home, who provided primperan (antiemetic and gut motility stimulator), diclofenaco (nsaid), antigen test (covid-19), and capillary blood glucose test (unspecified result).The caller did not report of further treatment.There was no report of death or permanent injury associated with this event.

• 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: 13727374
• MDR Text Key: 286994348
• Report Number: 2954323-2022-08036
• 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,Followup
• Report Date: 10/26/2022

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 75175-83
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 108 KG