ACCU-CHEK AVIVA 06870287001Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00365702544109), received between Sep 19, 2019 and Aug 6, 2024 — classified as 8 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS UNAVAILABLE FOR USE DUE TO NO POWER DURING A SERIOUS INJURY EVENT RESULTING IN HOSPITALIZATION. THE PATIENT TRIED TO USE THE METER ON THE INCIDENT DAY, BUT THE METER WOULD NOT TURN ON. THE CUSTOMER WAS FEELING NORMAL AND EXHIBITED NO SYMPTOMS. NONETHELESS, THE PATIENT'S MOTHER CALLED THE PARAMEDICS AS THEY HAD NO SPARE METER AVAILABLE TO TEST. WHEN THE PARAMEDICS ARRIVED THEY MEASURED A BLOOD GLUCOSE VALUE OF 900 MG/DL ON THE PARAMEDICS' METER, AND ASKED THE CUSTOMER A SERIES OF QUESTIONS, WITHOUT TREATING HER. ABOUT 15 MINUTES LATER, THEY TOOK HER TO THE HOSPITAL, WHERE SHE WAS ADMITTED FOR 16 DAYS. NO BLOOD GLUCOSE RESULTS OBTAINED BY THE HOSPITAL PERSONNEL WERE PROVIDED. THE PATIENT WAS TREATED FOR KETOACIDOSIS WITH INSULIN AND OTHER FLUIDS VIA IV WHILE IN THE HOSPITAL. THE PATIENT WAS ALSO PUT ON A VENTILATOR.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 19918231 ↗
• MalfunctionJul 27, 2022Incorrect Measurement; Incorrect Measurement

  UPON REVIEW BY THE MANUFACTURER'S INVESTIGATION UNIT, THE BLOOD GLUCOSE DEVICE WAS READING IN THE INCORRECT UNIT OF MEASURE FOR WHICH IT WAS LABELED. THE DEVICE BLOOD GLUCOSE RESULTS WERE IN MMOL/L AND METER WAS LABELED IN MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114682 ↗
• MalfunctionDec 22, 2020Melted; Melted

  IT WAS REPORTED THAT THE "METER GOT HOT AND THE BATTERY MELTED THE BACK."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11055347 ↗
• MalfunctionNov 10, 2020Overheating of Device; Overheating of Device

  THE MANUFACTURER'S FIRST LEVEL INVESTIGATION UNIT REPORTS SIGNS OF BURNING/MELTING ON THE BLOOD GLUCOSE METER. NO ADVERSE EVENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10816261 ↗
• InjurySep 11, 2020Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WOULD NOT TURN ON WHILE THE PATIENT EXPERIENCED HYPOGLYCEMIA. THE PATIENT EXPERIENCED SYMPTOMS OF LOW BLOOD GLUCOSE AND THE BLOOD GLUCOSE MONITOR HAD NO POWER WHEN SHE ATTEMPTED TO USE THE DEVICE. THE PATIENT PASSED OUT AND WAS UNCONSCIOUS AT AN UNKNOWN TIME ON (B)(6) 2020. THE PATIENT'S SON DISCOVERED HER AND TREATED THE PATIENT WITH GLUCOSE GEL. THE PATIENT WAS NOT TAKEN TO THE HOSPITAL.

  Patient problems: Hypoglycemia

  MAUDE report 10525165 ↗
• MalfunctionJul 30, 2020Melted; Melted

  IT WAS REPORTED THAT THE BATTERIES IN THE METER EXPLODED AND BATTERY ACID MELTED THE BACK OF THE METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10343475 ↗
• MalfunctionJun 29, 2020Explosion; Explosion

  IT WAS REPORTED THAT METER EXPLODED. THE PATIENT ADVISED THAT AFTER RUNNING HIS BLOOD SUGAR TEST YESTERDAY HE TOOK THE TEST STRIP OUT AND THE METER WAS SITTING ON HIS LEG AND IT BLEW UP AND BROKEN INTO SEVERAL SMALL PIECES. CUSTOMER DISCARDED THE PIECES OF THE METER. HE ADVISED HE FOUND THE BATTERY AND IT DID NOT APPEAR TO BE MELTED OR CORRODED. HE ADVISED METER HAD NOT BEEN EXPOSED TO ANY EXTREME HEAT OR A HEAT SOURCE AND HE DOES NOT KNOW WHY IT EXPLODED. HE ADVISED THAT THE METER DID NOT FEEL HOT TO HIM PRIOR TO EXPLODING AND IT DID NOT INJURE OR BURN HIM WHEN IT EXPLODED. HE DID NOT SEE ANY FIRE OR MELTING OF THE METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10205853 ↗
• MalfunctionJun 12, 2020Fire; Melted; Fire; Melted

  IT WAS REPORTED DEVICE EXPLODED AND CAUGHT FIRE AND WAS MELTED. THE PATIENT STATED SHE HEARD A LOUD "POP" AND SAW BLACK SMOKE AND FLAMES COMING FROM HER METER CARRYING CASE AND SHE DOUSED THE METER WITH WATER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10148030 ↗
• InjuryJan 29, 2020Incorrect, Inadequate or Imprecise Result or Readings; Power Problem; Incorrect, Inadequate or Imprecise Result or Readings; Power Problem

  AT 8:30 AM THE PATIENT RECEIVED A BLOOD GLUCOSE RESULT IN THE 200'S MG/DL ON HER AVIVA SYSTEM. BASED ON THE ELEVATED RESULT THE PATIENT INCREASED HER INSULIN DOSAGE AND TOOK 20 UNITS OF NOVOLOG INSULIN AT 8:30 AM. THE PATIENT'S NORMAL DOSAGE IS 10 UNITS OF NOVOLOG. THE PATIENT WENT TO A ROUTINE DOCTOR'S APPOINTMENT AT 11:00 AM AND THE DOCTOR CHECKED THE PATIENT'S BLOOD GLUCOSE AND RECEIVED A RESULT OF 113 MG/DL ON THE DOCTOR'S METER. AT 1:00 PM UPON ARRIVING HOME THE HUSBAND STATES THE PATIENT WAS PALE AND UNRESPONSIVE, BUT CONSCIOUS. THE HUSBAND ATTEMPTED TO TEST THE PATIENT AT 1:00 PM WITH THE AVIVA METER BUT RECEIVED AN E-9 MESSAGE. THE HUSBAND THEN PHONED ACCU-CHEK AND A METER RESET WAS PERFORMED. AT 1:20 PM WHILE ON THE LINE TROUBLESHOOTING, THE HUSBAND WAS ABLE TO RE-TEST THE PATIENTS BLOOD GLUCOSE AND RECEIVED A RESULT OF 108 MG/DL. THE PATIENT WAS SLUMPED OVER IN THE CHAIR. THE HUSBAND DISCONNECTED THE CALL WITH ACCU-CHEK AND CALLED 911. THE HUSBAND CALLED THE EMT'S AT 1:35 PM AND THE EMT'S ARRIVED AROUND 1:50 PM. UPON ARRIVAL THE EMT'S RECEIVED A BLOOD GLUCOSE RESULT OF 48 MG/DL ON THEIR PROFESSIONAL METER. THE EMT'S TREATED THE PATIENT WITH A PEANUT BUTTER SANDWICH AND OR

  Patient problems: Hypoglycemia

  MAUDE report 9642445 ↗
• InjuryJan 29, 2020Power Problem; Power Problem

  IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS UNAVAILABLE FOR USE DUE TO POWER CONCERNS. ON THE MORNING OF (B)(6) 2019 THE PATIENT ATTEMPTED TO TEST HER BLOOD GLUCOSE AND RECEIVED AN E-9 MESSAGE. THE PATIENT TOOK HER NORMAL DOSAGE OF MEDICATION. AT APPROXIMATELY 2:30-3:00 PM THE PATIENT WAS AT LUNCH WITH FRIENDS AND STATED THAT SHE BEGAN TO FEEL WEIRD AND BECAME UNRESPONSIVE. THE PATIENT ATTEMPTED TO TEST HER BLOOD GLUCOSE AT THIS TIME AND RECEIVED AN E-9 MESSAGE. NO RESTAURANT EMPLOYEES OR FRIENDS PROVIDED TREATMENT TO THE PATIENT, BUT THEY CALLED EMT'S. IT WAS REPORTED THAT THE EMT'S DID NOT TEST HER BLOOD GLUCOSE LEVEL ON THEIR DEVICE, BUT DID TREAT HER WITH AN IV. THE CONTENTS OF THE IV WERE UNKNOWN. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE BLOOD GLUCOSE RESULTS RECEIVED AT THE HOSPITAL WERE ELEVATED. THE TYPE OF MEDICATION OR TREATMENT PROVIDED BY THE HOSPITAL WAS UNKNOWN. HOWEVER, CALLER REPORTED THAT SHE WAS GIVEN HER NORMAL MEDICATION'S. THE PATIENT WAS HOSPITALIZED FOR 4 DAYS.

  Patient problems: Hyperglycemia

  MAUDE report 9642422 ↗
• InjuryJan 16, 2020Loss of Power; Loss of Power

  IT WAS REPORTED METER WAS UNAVAILABLE FOR USE WHEN CUSTOMER REPORTEDLY EXPERIENCED HYPERGLYCEMIA SYMPTOMS OF DIZZINESS, DELAYED BREATHING/SHORTNESS OF BREATH, SEEING BLACK SPOTS, SWEATING AND HEADACHES RESULTING IN LOSS OF CONSCIOUSNESS AND REQUIRING HOSPITALIZATION. THE PATIENT WAS TREATED WITH AN IV OF UNKNOWN CONTENT AND INSULIN.

  Patient problems: Hyperglycemia

  MAUDE report 9595716 ↗
• InjuryJan 15, 2020Power Problem; Power Problem

  IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS UNAVAILABLE FOR USE DUE TO POWER CONCERNS. ON THE MORNING OF (B)(6) 2019 THE PATIENT ATTEMPTED TO TEST HER BLOOD GLUCOSE AND RECEIVED AN E-9 MESSAGE. THE PATIENT TOOK HER NORMAL DOSAGE OF MEDICATION. AT APPROXIMATELY 2:30-3:00 PM THE PATIENT WAS AT LUNCH WITH FRIENDS AND STATED THAT SHE BEGAN TO FEEL WEIRD AND BECAME UNRESPONSIVE. THE PATIENT ATTEMPTED TO TEST HER BLOOD GLUCOSE AT THIS TIME AND RECEIVED AN E-9 MESSAGE. NO RESTAURANT EMPLOYEES OR FRIENDS PROVIDED TREATMENT TO THE PATIENT, BUT THEY CALLED EMT'S. IT WAS REPORTED THAT THE EMT'S DID NOT TEST HER BLOOD GLUCOSE LEVEL ON THEIR DEVICE, BUT DID TREAT HER WITH AN IV. THE CONTENTS OF THE IV WERE UNKNOWN. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE BLOOD GLUCOSE RESULTS RECEIVED AT THE HOSPITAL WERE ELEVATED. THE TYPE OF MEDICATION OR TREATMENT PROVIDED BY THE HOSPITAL WAS UNKNOWN. HOWEVER, CALLER REPORTED THAT SHE WAS GIVEN HER NORMAL MEDICATION'S. THE PATIENT WAS HOSPITALIZED FOR 4 DAYS.

  Patient problems: Hyperglycemia

  MAUDE report 9590745 ↗
• InjuryJan 14, 2020Loss of Power; Loss of Power

  IT WAS REPORTED CUSTOMER EXPERIENCED HIGH BLOOD SUGAR REQUIRING HOSPITALIZATION WHEN METER WAS UNAVAILABLE DUE TO NO POWER. THE TYPE OF TREATMENT RECEIVED WAS NOT PROVIDED.

  Patient problems: Hyperglycemia

  MAUDE report 9586574 ↗
• MalfunctionNov 22, 2019Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR DISPLAYED RESULTS IN MMOL/L INSTEAD OF MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9362743 ↗
• MalfunctionOct 25, 2019Incorrect Measurement; Incorrect Measurement

  CUSTOMER STATES THAT HER AVIVA SYSTEM READS IN MMOL/L, RATHER THAN MG/DL. CUSTOMER INDICATES THAT A READING OF 10.3 WAS OBTAINED ON THE DEVICE. NO ACTIONS TAKEN BASED ON DEVICE RESULT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241202 ↗
• MalfunctionOct 10, 2019Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE METER READS IN MMOL/L RATHER THAN MG/DL. RESULTS IN THE METER MEMORY INDICATES THAT READINGS ARE STORED AS MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9175798 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR DISPLAYED A POWER ISSUE ERROR MESSAGE ON THE NIGHT OF (B)(6) 2019 AT AN UNKNOWN TIME. AROUND 12:00 A.M. ON (B)(6) 2019, THE PATIENT WAS YELLING INCOHERENTLY. SHE WAS STILL CONSCIOUS, BUT WAS UNABLE TO SELF-TREAT. THE PATIENT'S SON CONTACTED THE PARAMEDICS IMMEDIATELY BECAUSE SHE WAS INCOHERENT AND NOT MAKING SENSE WHEN RESPONDING TO QUESTIONS. UPON ARRIVING WITHIN 5 TO 10 MINUTES, THE BLOOD GLUCOSE RESULT WAS 25 MG/DL ON THE PARAMEDIC'S METER. THE PATIENT WAS TREATED WITH AN UNKNOWN SUBSTANCE VIA IV. THE PATIENT ARRIVED AT THE HOSPITAL AROUND 12:45 A.M. WHERE SHE WAS TREATED WITH AN IV OF AN UNKNOWN SUBSTANCE, FOOD, AND JUICE. THE BLOOD GLUCOSE RESULT UPON ARRIVAL AT THE HOSPITAL WAS NOT PROVIDED. THE PATIENT WAS RELEASED FROM THE HOSPITAL AROUND 4:00 P.M. ON (B)(6) 2019.

  Patient problems: Hypoglycemia

  MAUDE report 9086886 ↗