Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
Recall
- Recall Number
- Z-1270-2025
- Event Number
- 96230
- Firm
- Telcare, LLC
- FEI Number
- 3008514395
- Product Code
- NBW
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- January 30, 2025
- Posted
- March 5, 2025
- Address
- 150 Baker Avenue, Ste 300, Concord, MA, 01742-2126
Description
Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The issue was identified by post market surveillance data (customer complaints) - events of battery expansion/swelling and associated symptoms, e.g., leading to the device's removable back cover (battery port) to separate. If there is a loss of primary function of the device due to the described device defect, an immediate health consequence that may result is prolonged hypoglycemia or hyperglycemia due to delay in treatment, as the blood glucose measurement is not available to guide treatment. In a worst-case situation, there is potential for battery swelling to result in explosion of the battery and/ or device. Exposure to explosion, and subsequently projectiles from the explosion, may result in several immediate health consequences, including concussion, headache, dizziness, eye irritation, blurred vision, eye injury, and vision impairment.
On January 30, 2025, an IMPORTANT Safety Notification message was pushed out to display on all meter devices. IMPORTANT Safety Notification: https://www.gobio.com/bgm - information on proper battery use. Mensaje importante sobre batera. What you should do: If you have a Philips or BioTel charger and your meter is working normally, you can keep using it. If you experience any of these issues, stop using your meter and contact Philips Customer Service at (888) 666-4530 (US) or (1) (978) 610-4688 (International): 1. The meter looks damaged or cracked. 2. The meter is swollen. 3. The meter is too hot to hold. 4. The meter won t hold a charge. 5. You don t have the Philips or BioTel charger. How to Charge your meter safely: 1. Only use the USB cable and power adapter that were included in your kit. They are blue and branded with Philips or BioTel. 2. Keep the meter and cables away from water. 3. Store the meter between 10C and 40C (50F and 104F). 4. Keep the meter and cables clean and dry. Make sure to follow these guidelines to prevent battery issues. What Philips is doing: Philips will update you on how to improve the battery usage as soon as possible. We also encourage you to perform a Meter Replacement Check to determine if your device is working properly. Safety and quality are our top priorities. For more information or support, call Philips Customer Service at (888) 666-4530 (US) or (1) (978) 610-4688 (International), Monday Friday from 9:00 AM to 9:00 PM Eastern Time, excluding major holidays. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax: 1. Complete and submit the report Online. 2. Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178).
US Nationwide distribution.
34,764 units