Accu-Chek Guide 08387052001Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00365702702431), received between Oct 7, 2020 and Apr 8, 2026 — classified as 8 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Melted” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Overheating of Device

  IT WAS REPORTED THAT THE BATTERIES EXPLODED WITHIN THE METER. THE BATTERY DOOR CANNOT BE OPENED BECAUSE IT IS BURNT AND THE BATTERIES CAN BE SEEN FROM THE EDGES OF THE DOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24813003 ↗
• MalfunctionNov 21, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE DISPLAY SCREEN ON THE BLOOD GLUCOSE MONITOR WAS "BURNED" BECAUSE IT LOOKED LIKE A RAINBOW. THE BLOOD GLUCOSE MONITOR WAS BRAND NEW AND THE DEFECT WAS APPARENT WHEN THE PATIENT RECEIVED THE PRODUCT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622071 ↗
• MalfunctionNov 14, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE USER'S MANUAL OF THE BLOOD GLUCOSE MONITOR IS IN SPANISH ONLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23551885 ↗
• InjuryApr 29, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT ON (B)(6) 2025, THE CUSTOMER EXPERIENCED ISSUES WITH HIGH BLOOD GLUCOSE LEVELS OF 500 MG/DL AND HYPERGLYCEMIA SYMPTOMS THAT LED TO HOSPITALIZATION. PRIOR TO THE INCIDENT, THE CUSTOMER HAD ATTEMPTED TO USE HER ACCU-CHEK GUIDE ME METER IN THE MORNING, BUT AN E-9 (= POWER PROBLEMS) WAS DISPLAYED. THE CUSTOMER DID NOT TAKE INSULIN BECAUSE SHE COULD NOT GET A READING ON HER METER. AT 1:00PM, THE CUSTOMER WAS DRIVEN TO HER DOCTOR BY HER DAUGHTER, AND THEN WAS ADMITTED TO THE HOSPITAL BY 2:00PM WITH A BLOOD GLUCOSE READING NEAR 500 MG/DL. THE PATIENT WAS TREATED WITH AN IV, 20-UNIT HUMALOG INJECTION, TYLENOL, AND A NOVOCAIN PATCH, SHE BRIEFLY LOST CONSCIOUSNESS. SHE WAS RELEASED AT 6:05PM WITH A READING OF 130 MG/DL, HER METER SHOWED 289 MG/DL AT 11:00PM. SHE STILL FEELS LIGHTHEADED, SHAKY, AND SLEEPY.

  Patient problems: Loss of consciousness

  MAUDE report 21926360 ↗
• MalfunctionNov 12, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS READING IN THE INCORRECT UNIT OF MEASURE FOR WHICH IT IS LABELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663408 ↗
• MalfunctionOct 4, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THE BATTERY OF THE OF THE BLOOD GLUCOSE MONITOR "IGNITED" AND THE METER BURNED/MELTED. THE USER REPORTED THAT THE BATTERY WAS NOT NEAR ANY HEAT SOURCE AT THE TIME THAT IT IGNITED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20376802 ↗
• MalfunctionMay 24, 2024Melted; Melted

  IT WAS REPORTED THAT THE METER WAS SMOKING AND BECAME VERY HOT. THE FRONT TOP OF THE BLOOD GLUCOSE MONITOR APPEARED TO BE MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19390311 ↗
• InjuryFeb 14, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS UNAVAILABLE FOR USE DUE TO SEVERAL STRIP ERRORS AND BATTERY/POWER MESSAGES. THE CALLER REPORTED THAT ON (B)(6) 2023 AT 3:00PM, THE CUSTOMER LOST CONSCIOUSNESS, DUE TO LOW BLOOD SUGAR. IT IS UNKNOWN HOW LONG THE CUSTOMER HAD BEEN UNCONSCIOUS. THE CUSTOMER'S MOTHER IN LAW FOUND HIM PASSED OUT AND CALLED 911. THE EMT'S ARRIVED BETWEEN 3:05PM AND 3:07PM. THE BLOOD GLUCOSE RESULT OBTAINED BY THE EMT'S WAS NOT PROVIDED. THE CUSTOMER WAS INITIALLY TAKEN TO THE HOSPITAL FOR AN INJURY SUSTAINED TO HIS THUMB DURING THE FALL AND THEN HE WAS TRANSPORTED TO A TRAUMA CENTER WHERE HE WAS ADMITTED FOR LOW BLOOD SUGAR, A BRAIN BLEED, AND BACK INJURY. THE CALLER REPORTED THAT THE CUSTOMER WAS UNABLE TO USE HIS METER PRIOR TO THE HOSPITALIZATION DUE TO THE MENTIONED ERROR MESSAGES. IT WAS REPORTED THAT THE CUSTOMER WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2023. HOWEVER, AT THE TIME OF THE INITIAL REPORT ON (B)(6) 2023, THE CUSTOMER'S WIFE MENTIONED THAT HE HAD GONE BACK INTO THE HOSPITAL AFTER RETURNING HOME LAST SUNDAY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Hypoglycemia

  MAUDE report 16373781 ↗
• MalfunctionJan 12, 2023Melted; Melted

  IT WAS REPORTED THAT THE DISPLAY SCREEN OF THE BLOOD GLUCOSE MONITOR APPEARED TO BE MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16148328 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR HYPERGLYCEMIA WHILE USING THE BLOOD GLUCOSE MONITOR. THE PATIENT WAS ABLE TO SUCCESSFULLY TEST ON HER BLOOD GLUCOSE MONITOR ON (B)(6) 2022 AT 5:00 P.M. THE SPECIFIC BLOOD GLUCOSE RESULT WAS UNKNOWN, BUT IT WAS WITHIN THE PATIENT'S NORMAL RANGE. THE PATIENT WAS NOT ABLE TO USE THE BLOOD GLUCOSE MONITOR AFTER THIS DUE TO A POWER ISSUE ERROR MESSAGE. ON (B)(6) 2022 AT AROUND 9:00 A.M., THE PATIENT WAS EXPERIENCING SYMPTOMS OF BEING SLEEPY AND INCOHERENT. THE PATIENT'S HUSBAND CONTACTED THE PARAMEDICS AT 10:00 A.M. AND THEY ARRIVED AT 10:05 A.M. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 550 MG/DL ON THE PARAMEDIC'S METER. THE PARAMEDICS DID NOT PROVIDE TREATMENT AND TRANSPORTED THE PATIENT TO THE HOSPITAL. IT IS UNKNOWN IF THE HOSPITAL TESTED THE PATIENT UPON ARRIVAL. THE TYPE OF TREATMENT PROVIDED TO THE PATIENT AT THE HOSPITAL WAS UNKNOWN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2022. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Hyperglycemia

  MAUDE report 16013186 ↗
• InjuryNov 25, 2022Power Problem; Power Problem

  THE CUSTOMER REPORTED THAT HER ACCU-CHEK GUIDE METER WAS UNAVAILABLE FOR USE, NOT POWERING ON DURING A SERIOUS INJURY EVENT. THE CUSTOMER WAS UNABLE TO SELF-TREAT AS SHE FELT VERY CONFUSED. SHE CALLED THE EMTS ON HER OWN BY PUSHING THE BUTTON ON A NECKLACE THAT SHE WEARS. UPON ARRIVAL, THEY TESTED ON THEIR OWN DEVICE AND THE READING ON THEIR METER WAS 52 MG/DL. THE EMT GAVE THE CUSTOMER GLUCOSE TABLETS, BUT SHE'S NOT SURE HOW MANY. SHE DOESN'T RECALL HOW LONG THEY STAYED OR IF THEY CHECKED HER BLOOD SUGAR AGAIN PRIOR TO LEAVING. SHE'S UNSURE HOW LONG IT TOOK FOR HER TO FEEL BETTER.

  Patient problems: Hypoglycemia

  MAUDE report 15864213 ↗
• InjuryOct 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS UNAVAILABLE FOR USE DUE TO A STRIP ERROR. ON (B)(6) 2022 THE PATIENT ATTEMPTED TO TEST HIS BLOOD GLUCOSE AND RECEIVED AN E-11 MESSAGE. ON (B)(6) 2022 THE CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS OF FEELING LIGHT HEADED AND DIZZY. THE CUSTOMER WAS UNABLE TO OBTAIN A READING ON THEIR GUIDE METER, DUE TO AN E11 MESSAGE. THE CUSTOMER TOOK HIS NORMAL DOSAGE OF MEDICATION AND AT 2:00PM WENT TO THE HOSPITAL. UPON ARRIVAL AT THE HOSPITAL, THE CUSTOMER RECEIVED A BLOOD GLUCOSE RESULT OF 277 MG/DL. THE CUSTOMER WAS TREATED FOR HYPERGLYCEMIA, HOWEVER THE TYPE OF TREATMENT RECEIVED WAS NOT PROVIDED. IT IS UNKNOWN HOW LONG THE CUSTOMER WAS HOSPITALIZED.

  Patient problems: Hyperglycemia

  MAUDE report 15536548 ↗
• InjuryOct 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CALLER ALLEGED AN INCIDENT WHERE THE METER WAS UNAVAILABLE FOR USE DUE TO AN E-4 MESSAGE ON (B)(6) 2021, AT AN UNKNOWN TIME. THE CUSTOMER EXPERIENCED SYMPTOMS OF HIGH BLOOD GLUCOSE LEVELS CONSISTING OF HEADACHE AND SWEATING. THE CUSTOMER WAS INCAPABLE OF PROVIDING SELF-TREATMENT AT THE TIME OF THE ERROR MESSAGE. AT 1:00AM, THE CUSTOMER WAS ABLE TO GET A SUCCESSFUL READING OF 400 MG/DL. THE REPORTER STATED THAT AFTER THE 400 MG/DL READING, SHE PROVIDED THE CUSTOMER WITH 34 UNITS OF LONG ACTING INSULIN (UNABLE TO RECALL THE NAME). SHE CALLED THE VA NURSE BECAUSE SHE WAS UNCERTAIN IF SHE HAD ADMINISTERED THE INSULIN CORRECTLY. THE CUSTOMER IS SCHEDULED TO TAKE 40 UNITS OF INSULIN, BUT OUT OF FEAR AND HER NON EXPERIENCE WITH ADMINISTERING MEDICATION SHE ONLY PROVIDED HIM WITH 34 UNITS. SHE RETESTED THE CUSTOMER WITH THE NURSE ON THE PHONE, AND THE RESULT WAS 300 MG/DL AT 1:15AM. THE NURSE ADVISED TO RECHECK LATER, BECAUSE HIS LEVELS WERE DECREASING. THE FINAL READING WAS AT 3:00AM, AND THE RESULT WAS 200 MG/DL. THE REPORTER STATED IT IS HARD TO DETERMINE HOW THE CUSTOMER IS FEELING BASED ON HIS OTHER HEALTH CONDITIONS. THE CUSTOMER ALWAYS HAS HEADACHE WHICH IS A PRIMARY SYMPTOM OF

  Patient problems: Hyperglycemia

  MAUDE report 12711853 ↗
• MalfunctionSep 3, 2021Melted; Melted

  IT WAS REPORTED THAT THE BATTERY DOOR OF THE BLOOD GLUCOSE MONITOR WAS MELTED AFTER THE DEVICE FAILED TO TURN ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12423802 ↗
• InjuryAug 25, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT THE PATIENT HAD A LOW BLOOD GLUCOSE LEVEL BECAUSE THE BLOOD GLUCOSE METER COULD NOT BE USED. ON THE MORNING OF THE INCIDENT DAY, THE PATIENT HAD MEASURED A BLOOD GLUCOSE LEVEL OF 134 MG/DL WITH HER METER. AROUND 4:15-4:20 PM, SHE FELT THAT HER BLOOD GLUCOSE WAS TOO LOW. SHE FELT DIZZY AND TRIED TO CHECK HER BLOOD GLUCOSE, BUT THE METER WOULD NOT TURN ON. SHE ASKED HER DAUGHTER TO RESET THE METER FOR HER, AND HER DAUGHTER TESTED HER BLOOD GLUCOSE WITH THE METER, WHICH WAS 74 MG/DL AT 4:23 PM. HER DAUGHTER GAVE HER SOME APPLE JUICE AND A SANDWICH TO TAKE HERSELF. HOWEVER, SHE BELIEVES THAT SHE COULD NOT HAVE GOTTEN THE JUICE OR FOOD DUE TO HER DIABETIC CONDITION AND COULD NOT RESET THE METER ON HER OWN OR TEST HER BLOOD GLUCOSE ON HER OWN WITHOUT ASSISTANCE. SHE STATED THAT SHE FELT BETTER HALF AN HOUR AFTER THE TREATMENT AND DID NOT TEST HER BLOOD GLUCOSE AGAIN UNTIL AROUND 9.30PM THE NIGHT BEFORE SHE WENT TO BED. THE VALUE WAS IN HER NORMAL RANGE OF ABOUT 120 MG/DL.

  Patient problems: Dizziness

  MAUDE report 12365017 ↗
• InjuryAug 2, 2021Power Problem; Power Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO HOSPITAL WITH A LOW BLOOD GLUCOSE LEVEL BECAUSE THE BLOOD GLUCOSE METER COULD NOT BE USED. ONE DAY BEFORE THE INCIDENT, THE PATIENT HAD MEASURED A BLOOD GLUCOSE LEVEL OF 160 MG/DL WITH HIS METER. THE NEXT DAY, HE WOKE UP AT 8:00 AM AND FELT DIZZY. HE TRIED TO USE THE METER, BUT THE METER TURNED OFF IMMEDIATELY AFTER HE TURNED IT ON. HE ADMINISTERED HIMSELF 10 UNITS OF LEVEMIR INSULIN BY PEN AND TOOK 6.25 MG OF ALOGLIPTIN INDEPENDENTLY. AS HE CONTINUED TO FEEL DIZZY, HE CALLED THE PARAMEDICS AT 9:00 AM. PARAMEDICS ARRIVED 10 MINUTES LATER AND DROVE HIM TO THE EMERGENCY ROOM. THE BLOOD GLUCOSE READINGS OR HOW THE PARAMEDICS TREATED HIM ARE NOT KNOWN. AT THE HOSPITAL, THE PATIENT WAS GIVEN FOOD AND DRINK TO TREAT HIS LOW BLOOD GLUCOSE LEVELS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL IN THE EVENING OF THE SAME DAY. BLOOD GLUCOSE READINGS MEASURED AT THE HOSPITAL ARE NOT KNOWN.

  Patient problems: Dizziness; Hypoglycemia

  MAUDE report 12263505 ↗
• MalfunctionJun 16, 2021Electrical Power Problem; Electrical Power Problem

  IT WAS REPORTED THAT THE BATTERIES SHOWED SIGNS OF BURNING INSIDE THE BLOOD GLUCOSE MONITOR. THERE WAS NO DAMAGE TO THE BLOOD GLUCOSE MONITOR ITSELF, BUT THE PATIENT BELIEVES THE DEVICE IS THE CAUSE SINCE THE BATTERIES WERE INSERTED 48 HOURS BEFORE THE BURN MARKINGS ON THE BATTERIES WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12010227 ↗
• MalfunctionApr 30, 2021Melted; Melted

  IT WAS REPORTED THAT THE SCREEN OF THE ACCU-CHEK GUIDE ME METER SHOWS SIGNS OF MELTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752583 ↗
• MalfunctionApr 15, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A BURN MARK WAS REPORTED TO COVER HALF OF THE METER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670655 ↗
• MalfunctionApr 6, 2021Incorrect Measurement; Incorrect Measurement

  CUSTOMER STATES THAT HIS GUIDE ME METER PRODUCED A BLOOD GLUCOSE RESULT OF 8.5. READINGS SHOULD BE IN MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11620835 ↗
• MalfunctionDec 23, 2020Melted; Melted

  IT WAS REPORTED THAT PART OF THE DISPLAY WAS MELTED AWAY ON THE BLOOD GLUCOSE MONITOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11067603 ↗
• MalfunctionOct 7, 2020Smoking; Smoking

  IT WAS REPORTED THAT THE GUIDE ME METER IS BURNT INSIDE THE BATTERY COMPARTMENT. THE CALLER REPORTED THAT THE METER HAD BEEN DROPPED IN WATER, AND THAT IS WHEN THEY NOTICED SMOKE. AFTER FURTHER OBSERVATION, THEY ALLEGED THE INSIDE OF THE BATTERY COMPARTMENT IS BURNT. THE CALLER STATED THAT THE METER AND BATTERIES WERE SAFE TO TOUCH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10643034 ↗