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

Model Number 72011-01

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2022

Event Type  malfunction  

Event Description

Customer reports the battery inside their adc device exploded.Customer further reports that the device may have dropped as signs of external damage is also present.There was no report of death, serious injury, or mistreatment associated with this event.

Manufacturer Narrative

The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reports the battery inside their adc device exploded.Customer further reports that the device may have dropped as signs of external damage is also present.There was no report of death, serious injury, or mistreatment associated with this event.

Manufacturer Narrative

Upon extended investigation, it was determined that the serial number provided by the customer ((b)(6)) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unk.Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned as of this report and a valid serial number has not been provided.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A tripped trend review was conducted for the reported complaint and fs precision pro meter, no trends were identified that would indicate any product related issues.If the product is returned, the case will be re-opened, and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.

Event Description

Customer reports the battery inside their adc device exploded.Customer further reports that the device may have dropped as signs of external damage is also present.There was no report of death, serious injury, or mistreatment associated with this event.

Manufacturer Narrative

Reader (b)(6) has been returned and investigated.Visual inspection has been performed and observed evidence of liquid ingress.The liquid ingress was caused by battery leakage from faulty/old batteries in the battery compartment.There was no evidence of fire/smoke/electric shock/explosion observed on the returned meter.Therefore, issue is not confirmed.An extended investigation has also been performed for the reported complaint and there was no indication that the product did not meet specification.No cable was returned for this complaint.Dhrs (device history record) for the freestyle precision pro meter were reviewed and the dhrs showed the freestyle precision pro meter passed all tests prior to release and the correct cable was part of the kit pack.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.Sections d4, h6, and h10 were incorrectly documented in the previous report submitted on 09nov22.All three sections have been updated and a returned product investigation has been added.

• Brand Name: FREESTYLE PRECISION PRO
• 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: 15620757
• MDR Text Key: 306820904
• Report Number: 2954323-2022-38273
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K132511
• 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,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 72011-01
• Device Catalogue Number: 72011-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1