Accu-Chek Guide 07453710001Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00365702710108), received between May 6, 2020 and Mar 3, 2026 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (16 reports).

2 other recalls cover devices cleared under the same FDA submission (K160944); they may or may not involve this specific model.

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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Imprecise or Erratic Results

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 330 MG/DL AND 130 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24494703 ↗
• MalfunctionJan 26, 2026Imprecise or Erratic Results

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 147 MG/DL AND 303 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24181497 ↗
• MalfunctionDec 15, 2025High Test Results; High Test Results

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 148 MG/DL (USER'S METER) AND 520 MG/DL (DIFFERENT ROCHE METER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802891 ↗
• MalfunctionMay 14, 2025High Test Results; High Test Results

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 353 MG/DL, 264 MG/DL, AND 162 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016450 ↗
• MalfunctionApr 29, 2025High Test Results; High Test Results

  THE CALLER REPORTED THAT THE BLOOD GLUCOSE DEVICE GAVE A HIGHER-THAN-EXPECTED READING DURING A HYPOGLYCEMIC EVENT. THE USER WAS EXPERIENCING LOW BLOOD GLUCOSE SYMPTOMS OF A HEADACHE, DIZZINESS, AND FEELING FAINT. THE USER TESTED ON HER GUIDE SYSTEM AND RECEIVED A BLOOD GLUCOSE RESULT OF 93 MG/DL, WHICH SHE FELT WAS ERRONEOUSLY HIGH. THE USER WAS UNABLE TO SELF-TREAT AND HER HUSBAND CALLED THE EMT'S. THE BLOOD GLUCOSE RESULT AND TREATMENT PROVIDED BY THE EMT'S WAS NOT PROVIDED. THE USER WAS TRANSPORTED TO THE HOSPITAL. THE BLOOD GLUCOSE RESULT OBTAINED AT THE HOSPITAL WAS NOT PROVIDED. THE USER WAS TREATED FOR LOW BLOOD GLUCOSE AT THE HOSPITAL, HOWEVER THE TYPE OF TREATMENT GIVEN WAS NOT PROVIDED. IT IS UNKNOWN HOW LONG THE CUSTOMER WAS HOSPITALIZED. THE USER DECLINED TO PROVIDE ANY FURTHER DETAILS.

  Patient problems: Hypoglycemia; Shaking/Tremors

  MAUDE report 21926454 ↗
• MalfunctionApr 22, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 35 MG/DL AND 120 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21879756 ↗
• MalfunctionMar 25, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 191 MG/DL AND 104 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687157 ↗
• MalfunctionFeb 4, 2025Low Test Results; Low Test Results

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 97 MG/DL, 62 MG/DL, AND 111 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21301844 ↗
• InjuryJul 23, 2024Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT WOKE UP AROUND 8:00 A.M. ON (B)(6) 2024 AND ATTEMPTED TO TEST HIS BLOOD GLUCOSE LEVEL MULTIPLE TIMES, BUT THE BLOOD GLUCOSE MONITOR KEPT DISPLAYING A TEST ERROR MESSAGE. THE LAST TIME THE PATIENT SUCCESSFULLY TESTED HIS BLOOD GLUCOSE LEVEL WAS THE NIGHT PRIOR TO THE EVENT AND THE RESULT WAS 175 MG/DL. THE PATIENT TOOK HIS NORMAL MEDICATION OF LABETALOL 100 MG, NIFEDIPINE 90 MG, AND 20 UNITS OF UNKNOWN INSULIN ON THE MORNING OF THE EVENT. THESE WERE NORMAL MEDICATIONS THAT HE TAKES EACH MORNING. THE PATIENT EXPERIENCED SYMPTOMS OF VERY SHAKY, DROWSY, AND NUMBNESS IN HIS LIMBS AT AROUND 9:00 A.M. THE PATIENT WAS UNCONSCIOUS FOR A FEW HOURS. HIS COUSIN FOUND HIM PASSED OUT AND WAS ABLE TO WAKE HIM UP ENOUGH TO GET HIM TO THE CAR WHERE HE WAS TRANSPORTED TO THE EMERGENCY ROOM BY HIS COUSIN. THE PATIENT ARRIVED AT THE EMERGENCY ROOM AT AROUND 12:00 P.M. AND HIS BLOOD LEVEL WAS 293 MG/DL. THE PATIENT WAS TREATED WITH AN IV OF UNKNOWN FLUIDS. THE PATIENT WAS UNDER OBSERVATION AND TREATMENT FOR 4 HOURS. THE PATIENT WAS RELEASED FROM THE EMERGENCY ROOM AT AROUND 4:00 P.M. WHEN HIS BLOOD LEVEL WAS BACK TO NORMAL WITH A RESULT OF 163 MG/DL.

  Patient problems: Loss of consciousness

  MAUDE report 19812196 ↗
• MalfunctionApr 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 291 MG/DL AND 130 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19079995 ↗
• MalfunctionApr 10, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 250-350 MG/DL AND 120-139 MG/DL. SUCH READINGS OCCURRED ON TWO OR THREE OCCASIONS OVER THE PREVIOUS 2-3 WEEKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19079943 ↗
• MalfunctionFeb 29, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 327 MG/DL AND 141 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809511 ↗
• MalfunctionFeb 13, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 220 MG/DL, 90 MG/DL, AND 230 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18697045 ↗
• MalfunctionJul 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 500'S MG/DL, EXACT VALUE UNKNOWN, AND 155 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17386063 ↗
• MalfunctionApr 4, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 168 MG/DL (LOT 1) AND LO (RESULT LESS THAN THE MEASURING RANGE OF THE SYSTEM, WHICH IS 20 MG/DL (LOT 2) ON THE SAME METER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16675929 ↗
• MalfunctionFeb 9, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 443 MG/DL AND 122 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16334457 ↗
• MalfunctionJan 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 268 MG/DL (PATIENT´S METER) AND 130 MG/DL (PROFESSIONAL´S METER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16224299 ↗
• MalfunctionMay 4, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 570 MG/DL AND 116 MG/DL. THE PATIENT EXPERIENCED SYMPTOMS OF TIREDNESS AND THIRST. SHE WAS CAPABLE OF SELF-TREATMENT.

  Patient problems: Hyperglycemia

  MAUDE report 14280381 ↗
• MalfunctionDec 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 256 MG/DL USING TEST STRIPS WITH LOT # 102725 AND 116 MG/DL USING TEST STRIPS WITH LOT # 102680.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13099236 ↗
• MalfunctionDec 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 256 MG/DL USING TEST STRIPS WITH LOT # 102725 AND 116 MG/DL USING TEST STRIPS WITH LOT # 102680.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13099113 ↗
• MalfunctionSep 20, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: HI MG/DL (WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL) AND 145 MG/DL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12496439 ↗
• MalfunctionAug 16, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 311 MG/DL AND 133 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12323496 ↗
• MalfunctionApr 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: OVER 600 MG/DL (SYSTEM 1) AND 127 MG/DL (SYSTEM 2).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11619997 ↗
• MalfunctionSep 2, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 49 MG/DL, 91 MG/DL, 102 MG/DL, AND 78 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10481055 ↗
• MalfunctionMay 6, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: A RESULT IN THE "400'S MG/DL RANGE" AND 160 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10028766 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K160944. One submission often covers many models, so check the product and lot details in each record.

• Z-2174-2024 · May 13, 2024 · Open, Classified
  Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectivenes
• Z-0747-2020 · Sep 30, 2019 · Terminated
  Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quan