Dario Blood Glucose Monitoring System 1015-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00850065006161), received between Oct 8, 2024 and Feb 19, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K150817, K163159); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  ON JANUARY 20TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HER DARIO METER A BG READING OF 230 MG/DL COMPARED TO A BG READING OF 110 MG/DL FROM HER CGM AND A BG READING OF 116 MG/DL FROM THE METER AT HER DOCTOR'S OFFICE. IN ADDITION, THE USER STATED THAT SHE RECEIVED AN A1C OF 6.8% AT HER DOCTOR'S OFFICE.

  Patient problems: Hyperglycemia

  MAUDE report 24393992 ↗
• MalfunctionSep 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  ON AUGUST 22ND, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS.THE USER REPORTED RECEIVING HIGH BG READINGS FOR THE PAST TWO MONTHS. SHE ALSO STATED THAT WHEN SHE OPENS A NEW CARTRIDGE, HER BG READINGS ARE IN NORMAL RANGE, HOWEVER WHEN THERE ARE SEVENTEEN TO TWENTY DAYS LEFT OF TESTING HER BG IN ORDER TO FINISH THE STRIPS CARTRIDGE, SHE RECEIVES HIGH BG READINGS.

  Patient problems: Hyperglycemia

  MAUDE report 23095968 ↗
• MalfunctionJul 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  ON JUNE 11TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER, WHO STATED THAT SHE HAS BEEN USING THE DARIO METER FOR MANY YEARS, REPORTED RECEIVING A BG READING OF 350 MG/DL FROM HER DARIO METER AFTER RETURNING HOME FROM THE FACILITY WHERE SHE RECEIVED AN INFUSION FOR HER DIABETES. THE USER REPORTED RECEIVING A BG READING OF 138 MG/DL AT THE FACILITY AFTER RECEIVING HER INFUSION.

  Patient problems: Hyperglycemia

  MAUDE report 22466648 ↗
• MalfunctionMay 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings

  ON APRIL 9TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT AND HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT RECENTLY, HE RETURNED TO USING HIS DARIO METER, AFTER NOT HAVING USED IT FOR THE PAST FIVE MONTHS. THE USER REPORTED THAT HE HAD PREVIOUSLY BEEN USING A NON-DARIO METER. THE USER REPORTED THAT FOR THE PAST TEN DAYS, HE WAS RECEIVING BG READINGS IN THE 200 MG/DL TO 300 MG/DL RANGE FROM HIS DARIO METER, HOWEVER WHEN TESTING IMMEDIATELY AFTERWARDS, HE RECEIVED BG READINGS IN THE 120 MG/DL RANGE FROM THE SAME DARIO METER, WHICH THE USER REPORTED ARE IN NORMAL RANGE FOR HIM.

  Patient problems: Hyperglycemia

  MAUDE report 21987299 ↗
• MalfunctionApr 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings

  ON MARCH 20TH, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS.THE USER REPORTED RECEIVING A BG READING OF ABOUT 170 MG/DL FROM HIS DARIO METER COMPARED TO A BG READING OF ABOUT 130 MG/DL FROM HIS NON-DARIO METER.

  Patient problems: Hypoglycemia

  MAUDE report 21870314 ↗
• MalfunctionFeb 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ON (B)(6), THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT ON (B)(6) AND ON THE FOLLOWING DAY, SHE RECEIVED THREE CONSECUTIVE DIFFERENT BG READINGS FROM HER DARIO METER. THE USER ALSO MENTIONED THAT SHE PURCHASED A NEW STRIPS CARTRIDGE SEVERAL DAYS PRIOR, HOWEVER IT IS UNCLEAR WHICH CARTRIDGE OF STRIPS THE USER HAD USED, WHEN SHE NOTICED THE INCONSISTENT BG READINGS.

  Patient problems: Insufficient Information

  MAUDE report 21369821 ↗
• MalfunctionOct 8, 2024Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings

  ON SEPTEMBER 8TH, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS.THE USER STATED THAT FOR THE PAST COUPLE OF YEARS, SHE HAS BEEN RECEIVING BG READINGS THAT WERE 30 MG/DL TO 50 MG/DL LOWER THAN HER ACTUAL BG READINGS FROM HER A1C.

  Patient problems: Hypoglycemia

  MAUDE report 20401936 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150817, K163159. One submission often covers many models, so check the product and lot details in each record.

• Z-0260-2020 · Aug 29, 2019 · Terminated
  Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2