BioTel Care BGM 4 TM0009Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00859519002407), received between May 26, 2023 and Feb 3, 2026 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 30, 2025Class IIOpen, Classified

   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.

   Z-1270-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Leak/Splash

  PATIENT ALLEGED THAT THEIR DEVICE LEAKED BATTERY ACID. THERE WAS NO ALLEGATION OF SERIOUS INJURY, AND NO MEDICAL ATTENTION WAS SOUGHT. RETURN EVALUATION OF THE AFFECTED DEVICE DID NOT CONFIRM THE ALLEGED ISSUE BUT FOUND THAT THE DEVICE CHARGING PORT HAD MELTED COMPONENTS INDICATIVE OF EXCESSIVE HEATING AT THE CHARGING PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246642 ↗
• MalfunctionJan 14, 2026Overheating of Device

  PATIENT ALLEGED THAT THE CHARGER PROVIDED WITH THEIR BIOTEL CONNECTED BLOOD GLUCOSE METER GOT HOT AND BECAME DISCOLORED WHILE CHARGING THE DEVICE. THERE WAS NO ALLEGATION OF SERIOUS INJURY, AND NO MEDICAL ATTENTION WAS SOUGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24070262 ↗
• MalfunctionOct 28, 2025Melted; Melted

  PATIENT ALLEGES THE CHARGER WOULD NOT STAY IN THE CHARGE PORT OF THEIR PHILIPS BLOOD GLUCOSE METER. THEY ALLEGE THE CONNECTION GOT LOST BETWEEN THE POWER CORD AND THE CHARGE PORT. THERE IS NO EVIDENCE OR ALLEGATION OF INJURY OR MEDICAL INTERVENTION. DURING RETURN INVESTIGATION OF THE METER, THERE WAS EVIDENCE OF MELTING AROUND THE CHARGE PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23406325 ↗
• MalfunctionSep 11, 2025Failure to Charge; Failure to Charge

  PATIENT ALLEGED THAT THE CHARGER FOR THEIR BIOTEL BGM WOULD NOT CHARGE THEIR DEVICE. THERE WAS NO ALLEGATION OR EVIDENCE OF INJURY OR MEDICAL ATTENTION SOUGHT BY THE PATIENT, AND NO ADDITIONAL INFORMATION WAS PROVIDED. WHEN THE CHARGER WAS RETURNED FOR EVALUATION, THE PLASTIC ON THE USB-C CONNECTOR WAS FOUND TO BE MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033369 ↗
• MalfunctionSep 11, 2025Crack; Fracture; Leak/Splash; Material Deformation; Thickening of Material; Crack; Fracture; Leak/Splash; Material Deformation; Thickening of Material

  PATIENT ALLEGED THAT THEIR BIOTEL CONNECTED BLOOD GLUCOSE METER EXPLODED AFTER LEAVING IT CONNECTED TO A CHARGER FOR ONE FULL DAY. THE PATIENT ALLEGED THEY WERE NOT PRESENT AT THE TIME OF THE EVENT AND DISCOVERED THE DAMAGE AFTER RETURNING TO THE ROOM WHERE IT HAD BEEN LEFT CHARGING. THE PATIENT DESCRIBED THE DEVICE AS BROKEN INTO MULTIPLE PIECES AND STATED THE DEVICE BATTERY WAS SWOLLEN. THE PATIENT ALSO ALLEGED THAT THE DEVICE HAD NEVER BEEN WARM TO THE TOUCH AND SAW NO SMOKE, SPARKS, MELTING, CHARRING, OR OTHER EVIDENCE OF EXCESSIVE HEAT. THERE WAS NO EVIDENCE OR ALLEGATION OF INJURY AND NO MEDICAL ATTENTION WAS SOUGHT BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031423 ↗
• MalfunctionFeb 24, 2025Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT ALLEGED THAT THEIR BIOTEL BLOOD GLUCOSE METER RETURNED READINGS THAT WERE TOO HIGH CAUSING THEM TO ADMINISTER TOO MUCH INSULIN AND BECOME LIGHTHEADED. NO SERIOUS INJURY WAS REPORTED AND THE PATIENT DID NOT SEEK MEDICAL ATTENTION.

  Patient problems: Dizziness

  MAUDE report 21451993 ↗
• MalfunctionJan 17, 2025Material Separation; Material Separation

  PATIENT CONTACTED CUSTOMER SUPPORT TO ALLEGE THAT THE POWER CORD FOR THEIR BIOTEL BLOOD GLUCOSE METER WAS DAMAGED. THE PATIENT ALLEGED THAT THE PRONGS SEPARATED FROM THE WALL ADAPTER AS IT WAS BEING REMOVED FROM A WALL OUTLET. THE PRONGS REMAINED PLUGGED IN AND HAD TO BE REMOVED SEPARATELY. THERE WAS NO ALLEGATION OF INJURY, AND NO MEDICAL ATTENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179146 ↗
• MalfunctionJan 13, 2025Material Separation; Material Separation

  PATIENT CONTACTED CUSTOMER SUPPORT TO ALLEGE THAT THE POWER CORD FOR THEIR BIOTEL BLOOD GLUCOSE METER WAS DAMAGED. THE PATIENT ALLEGED THAT THE PRONGS SEPARATED FROM THE POWER CORD WALL ADAPTER AS IT WAS BEING REMOVED FROM A WALL OUTLET. THERE WAS NO ALLEGATION OF INJURY, AND NO MEDICAL ATTENTION WAS SOUGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21140068 ↗
• MalfunctionDec 4, 2024Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT ALLEGEDLY CHECKED THEIR BLOOD SUGAR USING THE PHILIPS BLOOD GLUCOSE METER AND GOT A RESULT OF 575 MG/DL. PATIENT THEN ALLEGEDLY SELF-ADMINISTERED INSULIN AND LOST CONSCIOUSNESS AND FELL. AFTER THE EVENT, THE PATIENT ALLEGES THEIR BLOOD GLUCOSE WAS IN THE LOW 40S. NO MEDICAL ATTENTION WAS SOUGHT BY THE PATIENT. THE DATE/TIME OF THE ALLEGED EVENT IS NOT KNOWN AT THIS TIME.

  Patient problems: Loss of consciousness

  MAUDE report 20848872 ↗
• MalfunctionAug 23, 2024Overheating of Device; Overheating of Device

  PATIENT ALLEGED THAT THEIR BLOOD GLUCOSE METER WOULD NOT CHARGE, AND THAT THE CHARGER GOT HOT WHILE PLUGGED IN. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE PATIENT AND NO INJURY OR PROPERTY DAMAGE WAS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049889 ↗
• MalfunctionAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CALLED 911 AFTER RECEIVING A VERY HIGH RESULT ON THEIR BLOOD GLUCOSE METER. WHEN THE PARAMEDICS ARRIVED AT THE PATIENT'S HOME, THEY TESTED THE PATIENT'S BLOOD GLUCOSE WITH A DIFFERENT DEVICE AND RECEIVED A RESULT 60 POINTS LOWER THAN THAT RETURNED BY THE PATIENT'S METER. THE PATIENT DID NOT INDICATE WHETHER THE COMPARED READINGS WERE TAKEN WITHIN 15 MINUTES OF ONE ANOTHER AND THE SPECIFIC VALUES OF THE COMPARED RESULTS WERE NOT PROVIDED. THE PATIENT DID NOT INDICATE WHETHER THEY PERFORMED CONTROL SOLUTION TESTS ON THEIR METER TO VERIFY DEVICE. THE PATIENT DID NOT ALLEGE INJURY AND DID NOT PROVIDE SPECIFIC DETAILS REGARDING ASSISTANCE PROVIDED BY PARAMEDICS OR WHETHER TREATMENT WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934584 ↗
• MalfunctionApr 9, 2024Incorrect Measurement; Incorrect Measurement

  PATIENT ALLEGED THAT THEIR BLOOD GLUCOSE METER WAS NOT ACCURATE AFTER COMPARING RESULTS WITH A METER FROM A DIFFERENT MANUFACTURER. THE PATIENT PERFORMED CONTROL SOLUTION TESTS ON THE DEVICE AND ALLEGED THAT ONE L1 TEST RESULT AND ONE L2 TEST RESULT WAS OUTSIDE THE SPECIFIED RANGE. THERE WAS NO ALLEGATION OF SYMPTOMS OR INJURY ASSOCIATED WITH THE EVENT AND NO TREATMENT OR MEDICAL ATTENTION WAS SOUGHT BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076290 ↗
• MalfunctionMar 25, 2024Overheating of Device; Overheating of Device

  PATIENT ALLEGED THAT THEIR BLOOD GLUCOSE METER CHARGER MELTED INTO THE METER ITSELF WHILE CONNECTED TO THE DEVICE. NO INJURY OR PROPERTY DAMAGE WAS ALLEGED AND NO MEDICAL ATTENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969538 ↗
• MalfunctionFeb 23, 2024Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  THE PATIENT REPORTED A CONCERN THAT THEIR BLOOD GLUCOSE IS NOT ACCURATE AFTER RECEIVING INCONSISTENT BACK-TO-BACK READINGS. DEVICE LOGS SHOW THAT ON (B)(6) 2024, A SERIES OF FOUR (4) BLOOD GLUCOSE READINGS WERE RECORDED BETWEEN 8:36 AM AND 8:38 AM. THE RESULTS WERE 69, 79, 107, AND 119 RESPECTIVELY. CONTROL SOLUTION TESTING WAS NOT PERFORMED AS THE PATIENT DID NOT HAVE CONTROL SOLUTION. NO SYMPTOMS OR INJURY WERE REPORTED, AND NO MEDICAL ATTENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18769106 ↗
• MalfunctionFeb 23, 2024Overheating of Device; Overheating of Device

  PATIENT REPORTED THEIR BLOOD GLUCOSE METER FELT HOT TO THE TOUCH AFTER BEING PLUGGED IN TO CHARGE. NO INJURY OR PROPERTY DAMAGE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768922 ↗
• MalfunctionFeb 2, 2024Material Fragmentation; Excessive Heating; Material Fragmentation; Excessive Heating

  ON (B)(6) 2024, A COMPLIANCE CALL WAS MADE TO CHECK IN ON THE PATIENT BECAUSE NO NEW BLOOD GLUCOSE READINGS WERE BEING TRANSMITTED FROM THEIR DEVICE. WHEN THE PATIENT ANSWERED, THEY STATED THAT THEY HADN'T BEEN USING THEIR BLOOD GLUCOSE METER BECAUSE IN OCTOBER THE BATTERY IN THE DEVICE EXPLODED AND TORE THE DEVICE APART TO THE POINT IT WAS NOT USABLE. THE PATIENT WAS NOT ABLE TO PROVIDE THE SPECIFIC DATE OF THE EVENT. THE PATIENT INDICATED THAT THEY HAD DISPOSED OF THEIR DEVICE AFTER THE EVENT. NO INJURY WAS REPORTED AND NO MEDICAL ATTENTION WAS SOUGHT BY THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631901 ↗
• MalfunctionJan 12, 2024Incorrect Measurement; Incorrect Measurement

  PATIENT REPORTED A CONCERN THAT THEIR BLOOD GLUCOSE METER WAS NOT ACCURATE AFTER OBTAINING BACK-TO-BACK BLOOD TEST RESULTS THAT WERE OVER 200 POINTS DIFFERENT. WHILE ON THE PHONE WITH A CUSTOMER SERVICE REPRESENTATIVE, THE PATIENT TOOK THREE BLOOD TESTS WITHIN 6 MINUTES AND RECEIVED RESULTS OF 273 MG/DL, 402 MG/DL, AND 142MG/DL. ADDITIONALLY, THREE LEVEL 1 AND THREE LEVEL 2 CONTROL SOLUTION TESTS WERE PERFORMED VIA TELEPHONE WITH THE PATIENT. ONE OF THE LEVEL 2 TEST RESULTS WAS OUT OF THE SPECIFIED RANGE. NO SYMPTOMS OR INJURY WERE REPORTED, AND NO SELF-TREATMENT OR MEDICAL ATTENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18505213 ↗
• MalfunctionAug 25, 2023Overheating of Device; Overheating of Device

  PATIENT'S AUTHORIZED CONTACT REPORTED THE METER WAS SITTING ON THE COUNTER WHEN THEY OBSERVED THE BACK OF THE DEVICE WAS BUBBLING/MELTING NEAR THE BATTERY. THE AFFECTED DEVICE WAS THROWN AWAY BY THE USER. NO INJURY OR PROPERTY DAMAGE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623530 ↗
• MalfunctionJul 7, 2023Failure to Charge; Loss of Power; Failure to Charge; Loss of Power

  PATIENT REPORTED THEY WERE UNABLE TO TURN ON OR CHARGE THE DEVICE BUT DID NOT ALLEGE INJURY OR DEVICE DAMAGE. THE DEVICE WAS RETURNED FOR EVALUATION AND INSPECTION. THE DEVICE WAS NOT OPERATIONAL, AND INSPECTION FOUND THAT THE BATTERY COVER WAS SLIGHTLY MELTED. WHEN THE BATTERY COVER WAS REMOVED, A CORNER OF THE BATTERY AND A PORTION OF THE BATTERY PORT WERE FOUND TO BE BURNED/MELTED.PATIENT REPORTED THEY WERE UNABLE TO TURN ON OR CHARGE THE DEVICE BUT DID NOT ALLEGE INJURY OR DEVICE DAMAGE. THE DEVICE WAS RETURNED FOR EVALUATION AND INSPECTION. THE DEVICE WAS NOT OPERATIONAL, AND INSPECTION FOUND THAT THE BATTERY COVER WAS SLIGHTLY MELTED. WHEN THE BATTERY COVER WAS REMOVED, A CORNER OF THE BATTERY AND A PORTION OF THE BATTERY PORT WERE FOUND TO BE BURNED/MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17279043 ↗
• InjuryMay 26, 2023Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings; Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings

  PATIENT CHECKED BLOOD SUGAR USING THE BIOTEL CARE BLOOD GLUCOSE METER AND GOT A RESULT OF 246 MG/DL. PATIENT TOOK 2 UNITS OF INSULIN AND ENDED UP PASSING OUT ON THE FLOOR. PATIENT WAS TAKEN BY AMBULANCE TO THE HOSPITAL TO STAY OVERNIGHT.

  Patient problems: Loss of consciousness

  MAUDE report 17011161 ↗