Dario® USB-C Blood Glucose Monitoring System 1152-05Recalls & reported problems
Labstyle Innovation Ltd · The Dario USB-C Blood Glucose Monitoring System is a compact, all-in-one blood glucose meter that is used in conjunction with a smart mobile device (SMD). The Dario USB-C meter is connected to a SMD through USB-C connector in order to provide the glucose meter with power. The SMD also provides an external display for the user to review blood glucose testing results via a mobile application downloaded to the SMD. The full process of blood glucose measurement is done on the glucose meter; the SMD does not provide any diagnostic or clinical analysis function. When connected to a SMD, the Dario USB-C glucose meter is agnostic both to the platform of the smart mobile device and to the model of the individual SMD within a platform. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Dario USB-C blood glucose meter is a small all-in-one meter that plugs into a phone for power and shows results in a mobile app. The 28 reports mostly describe readings that don't match lab results or other meters, with users citing both high and low values. There are28 malfunction reports, with no deaths and no injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00850065006390), received between Nov 17, 2024 and May 22, 2026 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (28 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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings28
- High Readings13
- Low Readings9
Patient problems
- Hyperglycemia13
- Hypoglycemia9
- Insufficient Information8
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
ON APRIL 23RD, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HIS DARIO METER AN EA1C OF 5.4% COMPARED TO AN A1C OF 6.7% FROM HIS BLOOD WORK.
Patient problems: Hypoglycemia
MAUDE report 25262765 ↗MalfunctionMay 12, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
ON APRIL 12TH, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HER DARIO METER A LOW BG READING OF 40 MG/DL, WHICH DID NOT ALIGN WITH HOW SHE WAS FEELING. FOLLOWING THE ABOVE, THE USER REPORTED THAT SHE RETESTED SEVERAL MINUTES LATER AND RECEIVED A BG READING THAT WAS IN NORMAL RANGE FOR HER.
Patient problems: Hypoglycemia
MAUDE report 25150815 ↗MalfunctionMay 3, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
ON APRIL 3RD, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING A LOW BG READING OF 87 MG/DL ON HER DARIO METER WHEN COMPARED TO A BG READING OF 123 MG/DL ON HER OLD METER.
Patient problems: Hypoglycemia
MAUDE report 25063105 ↗MalfunctionMar 30, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON (B)(6), THE USER, WHO IS A TYPE 2 DIABETIC AND LONG TIME USER OF THE DARIO METER, CONTACTED DARIO TO REPORT HIGH AND INCONSISTENT BLOOD GLUCOSE (BG) READINGS.THE USER REPORTED THAT SEVERAL MONTHS AGO, HE WAS RECEIVING BG READINGS IN NORMAL RANGE FOR HIM FROM HIS DARIO METER. THE USER STATED THAT SEVERAL WEEKS AGO, HE OPENED A NEW CARTRIDGE OF STRIPS AND BEGAN RECEIVING BG READINGS THAT WERE INCONSISTENT. THE USER REPORTED THAT HIS NORMAL RANGE OF BG READINGS IS BETWEEN 120 MG/DL AND 145 MG/DL. AT THE TIME OF RECEIVING INCONSISTENT BG READINGS, THE USER RECEIVED A BG RANGE OF 170 MG/DL TO 190 MG/DL FROM HIS DARIO METER. THE USER STATED THAT WITHIN FIVE MINUTES, HE RETESTED WITH THE SAME STRIPS LOT AND RECEIVED BG READINGS FROM HIS DARIO METER THAT WERE 30 MG/DL TO 40MG/DL LOWER THAN HIS PREVIOUS READINGS. THE USER ALSO REPORTED THAT ON THE MORNING OF THE 1ST OF MARCH, HE TESTED HIS BG AND RECEIVED A READING OF 178 MG/DL. THE USER STATED THAT HE THEN RETESTED WITH A DIFFERENT LOT OF STRIPS AND RECEIVED A BG READING OF 135 MG/DL.
Patient problems: Hyperglycemia; Insufficient Information
MAUDE report 24735126 ↗MalfunctionMar 15, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
ON FEBRUARY 17TH, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING BG READINGS FROM HIS DARIO METER THAT WERE 25 MG/DL TO 30 MG/DL LOWER THAN HIS PREVIOUS BG READINGS. THE USER ALSO REPORTED THAT HE RECENTLY HAD LAB WORK DONE, WHERE HE RECEIVED A BG READING OF 109 MG/DL AND AN A1C OF 5.8%. THE USER STATED THAT ON THAT SAME DAY OF RECEIVING THE BLOOD WORK, HE RECEIVED FROM HIS DARIO METER A BG READING OF 82 MG/DL. DUE TO THE ABOVE, THE USER STATED THAT HIS DOCTOR ADVISED HIM TO FOLLOW UP ON HIS BG READINGS WITH THE DARIO METER.
Patient problems: Hypoglycemia
MAUDE report 24601691 ↗MalfunctionMar 8, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON FEBRUARY 9TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING BG READINGS FROM HIS DARIO METER THAT ARE 30 MG/DL HIGHER THAN HIS NON-DARIO METER.
Patient problems: Hyperglycemia
MAUDE report 24541777 ↗MalfunctionFeb 12, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON JANUARY 14TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED A BG READING OF 120 MG/DL FROM HIS DARIO METER, FOLLOWED BY A BG READING OF 99 MG/DL FIFTEEN MINUTES LATER. THE USER ALSO REPORTED A BG READING OF 133 MG/DL FROM HIS DARIO METER THE FOLLOWING MORNING, FOLLOWED BY A BG READING OF 114 MG/DL SEVERAL MINUTES LATER. DUE TO THE ABOVE THE USER STATED THAT HE TESTED WITH HIS NON-DARIO METER AND RECEIVED A BG READING OF 108 MG/DL, WHICH THE USER STATED WAS SIMILAR TO THE READINGS THAT HE RECEIVED FOM HIS LAB RESULTS.
Patient problems: Hyperglycemia
MAUDE report 24324821 ↗MalfunctionDec 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON NOVEMBER 4TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS.THE USER REPORTED RECEIVING FROM HER DARIO METER BG READINGS THAT WERE 50 MG/DL HIGHER THAN THE BG READINGS THAT SHE RECEIVED USING HER NON-DARIO METER.
Patient problems: Hyperglycemia
MAUDE report 23706878 ↗MalfunctionNov 27, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON (B)(6), THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT HIS RECENT A1C RESULT OF 6.9% DOES NOT ALIGN WITH HIS BG READINGS OF MORE THAN 200 MG/DL THAT HE HAS BEEN RECEIVING FROM HIS DARIO METER. THE USER ALSO STATED THAT HE USED CONTROL SOLUTION MULTIPLE TIMES, WHICH INDICATED THAT HIS DARIO STRIPS ARE READING WITHIN RANGE. DESPITE THE CONTROL SOLUTION RESULTS, THE USER STATED THAT HE STILL SUSPECTED THAT HIS BG READINGS WERE INACCURATE, AND THEREFORE WAS RECOMMENDED BY HIS PROVIDER TO PURCHASE AND USE A NON-DARIO METER. THE USER REPORTED THAT THE BG READINGS THAT HE RECEIVES FROM HIS DARIO METER ARE CONSISTENTLY 65 MG/DL HIGHER THAN THE BG READINGS THAT HE RECEIVES FROM HIS NON-DARIO METER.
Patient problems: Hyperglycemia
MAUDE report 23666094 ↗MalfunctionNov 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON OCTOBER 21ST THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HIS DARIO METER BG READINGS THAT WERE CONSISTENTLY 14 MG/DL HIGHER THAN HIS TWO OTHER NON-DARIO METERS. THE USER STATED THAT HE TESTED ALL THREE METERS WITH THE SAME DROP OF BLOOD.
Patient problems: Hyperglycemia
MAUDE report 23599114 ↗MalfunctionNov 6, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON OCTOBER 7TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT AND HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THE FOLLOWING BG READING COMPARISONS BETWEEN THE USER'S NON-DARIO METER AND HIS DARIO METER, RESPECTIVELY: 102 MG/DL VS. 116 MG/DL, 109 MG/DL VS. 127 MG/DL, 125 MG/DL VS. 188 MG/DL, 114 MG/DL VS. 154 MG/DL, 130 MG/DL VS. 164 MG/DL, 109 MG/DL VS. 130 MG/DL, 87 MG/DL VS. 99 MG/DL, 106 MG/DL VS. 132 MG/DL, 109 MG/DL VS. 126 MG/DL, 101 MG/DL VS. 128 MG/DL, 141 MG/DL VS. 177 MG/DL, AND 119 MG/DL VS. 137 MG/DL. THE USER STATED THAT HE WAS USING THE SAME DROP OF BLOOD AND THAT THE READINGS WERE TAKEN CONSECUTIVELY.
Patient problems: Hyperglycemia
MAUDE report 23491100 ↗MalfunctionOct 30, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON OCTOBER 1ST, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED SEEING SIGNIFICANT DIFFERENCES BETWEEN BG READINGS WHEN TESTING WITH A NEW CARTRIDGE OF STRIPS, WITH THE SAME DROP OF BLOOD.
Patient problems: Insufficient Information
MAUDE report 23424216 ↗MalfunctionOct 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
ON SEPTEMBER 18TH, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS.THE USER REPORTED RECEIVING FROM HER DARIO METER TWO BG READINGS OF 44 MG/DL EACH COMPARED TO A BG READING OF 160 MG/DL FROM THE USER'S PREVIOUS, NON-DARIO, METER.
Patient problems: Hypoglycemia
MAUDE report 23317155 ↗MalfunctionSep 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON (B)(6), THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HIS DARIO METER CONSECUTIVE BG READINGS OF 500 MG/DL, 300 MG/DL AND 215 MG/DL.
Patient problems: Hyperglycemia
MAUDE report 23066624 ↗MalfunctionSep 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON (B)(6), THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED TESTING MULTIPLE TIMES AND RECEIVING HIGH BG READINGS FROM HIS DARIO METER WHEN COMPARED TO HIS NON-DARIO METER.
Patient problems: Hyperglycemia
MAUDE report 23037196 ↗MalfunctionSep 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON AUGUST 6TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER STATED THAT HER DARIO METER DOES NOT READ CORRECTLY, AND THEREFORE, SHE PREFERS TO USE HER OLD NON-DARIO METER.
Patient problems: Hyperglycemia
MAUDE report 22954653 ↗MalfunctionAug 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
ON (B)(6), THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER, WHO RECENTLY RECEIVED HIS DARIO METER, REPORTED RECEIVING A BG READING OF 130 MG/DL WITH THE DARIO METER COMPARED TO A BG READING OF 178 FROM HIS NON-DARIO METER. THE USER STATED THAT AFTER CLEANING WITH ALCOHOL, HE RECEIVED A BG READING OF 144 MG/DL FROM HIS DARIO METER COMPARED TO A BG READING OF 179 MG/DL FROM HIS NON-DARIO METER.
Patient problems: Hypoglycemia
MAUDE report 22833474 ↗MalfunctionAug 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON JULY 18TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS.THE USER REPORTED THAT WHILE SHE WAS AT A PRE-SCHEDULED DOCTOR'S APPOINTMENT, SHE TESTED HER BG AND RECEIVED A READING OF OVER 400 MG/DL FROM HER DARIO METER COMPARED TO A BG READING OF 144 MG/DL WHICH SHE RECEIVED FROM HER DOCTOR'S BG METER.
Patient problems: Hyperglycemia
MAUDE report 22824779 ↗MalfunctionAug 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
ON (B)(6), THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING BG READINGS THAT WERE 10 MG/DL TO 15 MG/DL DIFFERENT THAN HIS NON-DARIO METER.
Patient problems: Hypoglycemia
MAUDE report 22747259 ↗MalfunctionJul 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON (B)(6), THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING INACCURATE BG READINGS COMPARED TO HIS OLD METER AND HIS A1C RESULTS. THE USER REPORTED BG READINGS FROM HIS DARIO METER THAT WERE 50+ MG/DL HIGHER THAN HIS OTHER DEVICE. THE USER ALSO STATED THAT HE TESTED HIS BG READINGS WITH A NEW CARTRIDGE OF STRIPS, HOWEVER RECEIVED THE SAME HIGH READINGS.
Patient problems: Hyperglycemia
MAUDE report 22532616 ↗MalfunctionJul 16, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON (B)(6), THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT WITHIN A MINUTE SHE RECEIVED THREE BG READINGS WITH HER DARIO METER THAT WERE HIGHER THAN HER NON-DARIO METER, WITH HER FIRST BG READING BEING 100 MG/DL HIGHER THAN HER NON-DARIO METER. THE USER REPORTED RECEIVING A BG READING OF 98 MG/DL FROM HER NON-DARIO METER.
Patient problems: Hyperglycemia
MAUDE report 22517303 ↗MalfunctionJul 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON JUNE 13TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER STATED THAT HE IS QUESTIONING THE ACCURACY OF HIS BG READINGS THAT HE RECEIVED FROM HIS DARIO METER.
Patient problems: Insufficient Information
MAUDE report 22480619 ↗MalfunctionJun 17, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
ON MAY 17TH, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING BG READINGS FROM HIS DARIO METER THAT WERE 30 MG/DL - 40 MG/DL LESS THAN THE BG READINGS THAT HE RECEIVED FROM HIS TWO OTHER NON-DARIO METERS. THE USER STATED THAT HE WEARS A CGM IN ADDITION TO TESTING WITH THE DARIO METER. THE USER REPORTED THAT HE WENT TO HIS DOCTOR AND DISCUSSED WITH HIM THE BG READINGS THAT HE RECEIVED FROM HIS DARIO METER.
Patient problems: Hypoglycemia; Insufficient Information
MAUDE report 22235902 ↗MalfunctionJun 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON MAY 13TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS.THE USER REPORTED RECEIVING FROM HER DARIO METER BG READINGS OF 98 MG/DL, 148 MG/DL, AND 150 MG/DL , ALL WITHIN SEVERAL MINUTES.
Patient problems: Insufficient Information
MAUDE report 22195531 ↗MalfunctionMar 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON FEBRUARY 11TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING BG READINGS FROM HER DARIO METER THAT WERE SIGNIFICANTLY DIFFERENT THAN HER OTHER GLUCOMETER.
Patient problems: Insufficient Information
MAUDE report 21562873 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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