Dario® USB-C Blood Glucose Monitoring System- Welcome Kit 1264-05Recalls & reported problems
Labstyle Innovation Ltd · The Dario USB-C Blood Glucose Monitoring System Welcome Kit 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 plugs into a phone to show blood sugar results. Reports mostly describe readings that were too high, too low, or inconsistent, often differing from other meters or repeated tests. There are 24 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
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00850065006741), received between Aug 15, 2024 and Apr 28, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (24 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 Readings24
- High Readings13
- Low Readings4
Patient problems
- Hyperglycemia12
- Insufficient Information7
- Hypoglycemia5
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Incorrect, 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 HER DARIO METER BG READINGS OF 171 MG/DL AND 181 MG/DL, WHICH THE USER STATED SCARED HER. DUE TO THE ABOVE, THE USER STATED THAT SHE CONSULTED WITH HER DARIO COACH, WHO SUGGESTED THAT THE USER MAY NEED A NEW METER.
Patient problems: Hyperglycemia
MAUDE report 25021698 ↗MalfunctionApr 6, 2026Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6), THE USER, WHO IS PRE-DIABETIC, CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FOUR CONSECUTIVE BG READINGS FROM HIS DARIO METER, TAKEN ONE MINUTE APART, RANGING FROM 156 MG/DL TO 260 MG/DL.
Patient problems: Insufficient Information
MAUDE report 24794602 ↗MalfunctionApr 6, 2026Incorrect, Inadequate or Imprecise Result or Readings
ON MARCH 8TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING BG READINGS THAT WERE HIGHLY VARIABLE WHEN USING HIS DARIO METER. DUE TO THE ABOVE, THE USER REQUESTED CONTROL SOLUTION.
Patient problems: Insufficient Information
MAUDE report 24794457 ↗MalfunctionFeb 26, 2026Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON JANUARY 27TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HER DARIO METER A BG READING OF 181 MG/DL COMPARED TO A BG READING OF 51 MG/DL FROM HER BACKUP METER AND CGM. THE USER ALSO REPORTED THAT THE BG READING OF 181 MG/DL DID NOT ALIGN WITH HOW SHE WAS FEELING.
Patient problems: Hypoglycemia
MAUDE report 24461514 ↗MalfunctionFeb 24, 2026Incorrect, Inadequate or Imprecise Result or Readings
ON JANUARY 26TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT HER DARIO TEST STRIPS GAVE HER DIFFERENT BG READINGS THAN HER OLDER TEST STRIPS. DUE TO THE ABOVE, THE USER REQUESTED CONTROL SOLUTION IN ORDER TO TEST THE STRIPS.
Patient problems: Insufficient Information
MAUDE report 24434407 ↗MalfunctionFeb 12, 2026Incorrect, 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 THAT WHEN HE FIRST BEGAN USING THE DARIO METER, HE RECEIVED BG READINGS THAT WERE 20 MG/DL TO 30 MG/DL LOWER WHEN COMPARED TO HIS NON-DARIO METER. THE USER ALSO REPORTED THAT ONE DAY PRIOR TO CONTACTING DARIO, HE RECEIVED A LOW BG READING OF 52 MG/DL FROM HIS DARIO METER, FOLLOWED BY A BG READING OF 122 MG/DL THE FOLLOWING MORNING. FOLLOWING THE ABOVE, THE USER TESTED HIS BG USING A NEW TEST STRIP AND LANCET AND RECEIVED A BG READING IN THE LOW 30 MG/DL RANGE FROM HIS DARIO METER.
Patient problems: Hypoglycemia
MAUDE report 24324128 ↗MalfunctionJan 7, 2026Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
ON DECEMBER 7TH, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED PERFORMING MULTIPLE, CONSECUTIVE BG TESTS WITH TWO OTHER NON-DARIO METERS, WHICH GAVE HER DIFFERENT READINGS. THE USED ALSO MENTIONED THAT SHE STOPPED USING THE DARIO METER DUE TO THE LOW BG READINGS SHE RECEIVED FROM IT.
Patient problems: Hypoglycemia
MAUDE report 23994142 ↗MalfunctionDec 28, 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 A MESSAGE FROM HER DARIO METER SAYING THAT FOUR OF HER BG READINGS WERE "LOW". THE USER STATED THAT SHE HAD NO SYMPTOMS OF HAVING LOW BLOOD GLUCOSE. THE USER REPORTED THAT THE FOLLOWING MORNING, SHE TESTED HER BG WITH HER DARIO METER AND RECEIVED A BG READING THAT WAS IN NORMAL RANGE FOR HER.
Patient problems: Hypoglycemia
MAUDE report 23903667 ↗MalfunctionNov 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON OCTOBER 14TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS.THE USER REPORTED RECEIVING BG READINGS FROM HER DARIO METER THAT WERE 50 MG/DL HIGHER THAN THE BG READINGS THAT SHE RECEIVED FROM HER NON-DARIO METER AND THE RESULTS THAT SHE RECEIVED FROM HER LABWORK.
Patient problems: Hyperglycemia
MAUDE report 23545331 ↗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 HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING A BG READING OF 222 MG/DL FROM HER DARIO METER COMPARED TO A BG READING OF 114 MG/DL FROM HER NON-DARIO METER.
Patient problems: Hyperglycemia
MAUDE report 23488077 ↗MalfunctionOct 15, 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 STATED THAT SINCE ON (B)(6) 2025, HER BG READINGS WERE IN THE RANGE OF 400 MG/DL TO 500 MG/DL USING HER DARIO METER. THE USER ALSO REPORTED THAT DUE TO THE ABOVE, THE USER CALLED HER DOCTOR, WHO DOUBLED HER DOSAGE OF METFORMIN. THE USER ADDED THAT SHE PURCHASED A NON-DARIO METER, WHICH GAVE HER BG READINGS IN THE 130 MG/DL TO 150 MG/DL RANGE. THE USER STATED THAT SHE INFORMED HER DOCTOR, WHO READJUSTED HER METFORMIN DOSAGE BACK TO THE ORIGINAL DOSAGE.
Patient problems: Hyperglycemia
MAUDE report 23278400 ↗MalfunctionSep 9, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON (B)(6) 2025, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING BG READINGS IN THE 500 MG/DL RANGE FROM HIS NEW DARIO METER AND HAS SINCE STOPPED USING IT TO MEASURE HIS BG. THE USER ALSO REPORTED THAT HE IS CURRENTLY USING A NON-DARIO METER AND RECEIVED BG READINGS OF 118 MG/DL AND 125 MG/DL, WHICH THE USER STATED WAS A NORMAL RANGE FOR HIM.
Patient problems: Hyperglycemia
MAUDE report 23002754 ↗MalfunctionSep 8, 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 BG READINGS IN THE 500 MG/DL RANGE FROM HIS DARIO METER COMPARED TO BG READINGS IN THE 100 MG/DL TO 110 MG/DL RANGE FROM THE USER'S OTHER NON-DARIO METERS.
Patient problems: Hyperglycemia
MAUDE report 22992013 ↗MalfunctionAug 21, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON JULY 23RD, THE USER CONTACTED DARIO TO REPORT THAT HE PERFORMED A CONTROL SOLUTION TEST IN ORDER TO VERIFY THE ACCURACY OF HIS DARIO METER AND TEST STRIPS AND THE RESULTS THAT HE RECEIVED WERE OUT OF RANGE.
Patient problems: Insufficient Information
MAUDE report 22862307 ↗MalfunctionAug 20, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON JULY 22ND, THE USER CONTACTED DARIO TO REPORT INCONSISTENT BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT FOLLOWING HIS FEELING THAT HIS BG WAS LOW, HE TESTED HIS BG WITH HIS DARIO METER AND RECEIVED A READING OF 78 MG/DL. FOLLOWING THE ABOVE, THE USER TOOK SOME GLUCOSE TABLETS AND RETESTED HIS BG, RECEIVING READINGS OF 328 MG/DL, 278 MG/DL AND 119 MG/DL. THE USER DID NOT MENTION HIS ACTIONS OR THE TIME THAT HAD ELAPSED BETWEEN THE DIFFERENT BG READINGS.
Patient problems: Insufficient Information
MAUDE report 22854280 ↗MalfunctionAug 18, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON JULY 21ST, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT ON THE NIGHT PREVIOUS TO CONTACTING DARIO, HE TESTED HIS BG USING HIS WIRELESS SENSOR DEVICE, AND RECEIVED READINGS BETWEEN 54 MG/DL AND APPROXIMATELY 100 MG/DL AT DIFFERENT TIMES. THE USER ALSO REPORTED THAT IN COMPARISON, HE RECEIVED BG READINGS OF 284 MG/DL, 286 MG/DL, AND 287 MG/DL FROM HIS DARIO METER.
Patient problems: Hyperglycemia
MAUDE report 22831431 ↗MalfunctionAug 13, 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 RECEIVING BG READINGS OF 245 MG/DL, 208 MG/DL, 104 MG/DL AND 183 MG/DL FROM HIS DARIO METER.
Patient problems: Insufficient Information
MAUDE report 22795038 ↗MalfunctionJul 2, 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 BG READINGS IN THE 130 MG/DL TO 140 MG/DL RANGE COMPARED TO A BG READING OF 90 MG/DL OR LOWER, WHICH THE USER STATED WAS A NORMAL RANGE FOR HIM. THE USER ADDED THAT HE HAD BEEN COMPARING WITHIN FIFTEEN MINUTES OF EACH OTHER, HIS BG READINGS WITH A NON-DARIO METER AND OBTAINED RESULTS WITH A 15 MG/DL TO 20 MG/DL DIFFERENCE.
Patient problems: Hyperglycemia
MAUDE report 22382418 ↗MalfunctionMay 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; Low Readings; Incorrect, Inadequate or Imprecise Result or Readings; Low Readings
ON APRIL 30TH, THE USER CONTACTED DARIO TO REPORT LOW BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING A LOW BG READING OF 55 MG/DL FROM HER DARIO METER WHEN HER NORMAL BG READING WAS 126 MG/DL.
Patient problems: Hypoglycemia
MAUDE report 22083381 ↗MalfunctionMay 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
ON (B)(6), THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING A DIFFERENCE OF 10 MG/DL IN HER BG READINGS FROM HER DARIO METER, WHEN TAKING MEASUREMENTS FROM DIFFERENT FINGERS.
Patient problems: Insufficient Information
MAUDE report 21961433 ↗MalfunctionApr 29, 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 SINCE STARTING TO USE A NEW CARTRIDGE OF STRIPS AND TESTING HER BG LEVELS IN THE MORNINGS, THE RESULTS HAVE BEEN HIGHER THAN HER USUAL RANGE. IN ADDITION, THE USER STATED THAT THERE WAS A TWENTY POINT DIFFERENCE BETWEEN TWO CONSECUTIVE BG READINGS.
Patient problems: Hyperglycemia
MAUDE report 21927354 ↗MalfunctionNov 17, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON OCTOBER 17TH, THE USER CONTACTED DARIO TO REPORT INCONSISTENT AND HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT SINCE AUGUST 2024, HE HAS BEEN RECEIVING INCONSISTENT AND HIGH BG READINGS FROM HIS DARIO METER.
Patient problems: Hyperglycemia
MAUDE report 20702489 ↗MalfunctionSep 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
ON AUGUST 9TH, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED RECEIVING FROM HIS DARIO METER BG READINGS HIGHER THAN 170 MG/DL. DUE TO THE ABOVE, THE USER WENT TO HIS DOCTOR, WHO SENT THE USER TO HAVE LAB TESTS PERFORMED. THE USER REPORTED THAT HE RECEIVED LAB TEST RESULTS THAT WERE IN RANGE, AND THAT HIS DOCTOR INSTRUCTED HIM TO STOP USING THE DARIO METER AND TO ORDER A REPLACEMENT GLUCOMETER.
Patient problems: Hyperglycemia
MAUDE report 20169304 ↗MalfunctionAug 15, 2024Incorrect, 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 HER DARIO METER BG READINGS OF OVER 300 MG/DL, WHICH WERE 60 MG/DL HIGHER THAN HER CGM AND NON-DARIO METER, WHICH WERE 5 MG/DL WITHIN EACH OTHER.
Patient problems: Hyperglycemia
MAUDE report 19989714 ↗
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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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