ReliOn™ Premier Classic Meter 784001Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00681131280624), received between Jun 5, 2024 and Aug 12, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “High Readings” (4 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT TWO DIFFERENT METERS, A RELION PREMIER CLASSIC AND A RELION PREMIER VOICE, AND TWO DIFFERENT LOTS OF PREMIER TEST STRIPS ARE READING TOO LOW WHICH CAUSED HER TO BELIEVE THAT HER BLOOD SUGAR WAS TOO LOW, SO SHE DRANK ORANGE JUICE TO RAISE HER BLOOD GLUCOSE LEVELS AND ENDED UP GOING TO THE EMERGENCY ROOM TO BE TREATED. SHE STATED HER NORMAL BLOOD GLUCOSE LEVELS ARE 90-100, HOWEVER SOMETIMES SHE RECEIVES LEVELS IN HIGHER HUNDREDS TO LOWER TWO HUNDREDS. SHE WAS RECEIVING RESULTS OF 50-60 TESTING WITH THESE PRODUCTS. WHEN ASKED ABOUT HAND CLEANSING, USING NEW LANCETS, AND BLOOD TESTING TECHNIQUES, SHE DESCRIBED PROPER BLOOD TESTING TECHNIQUES. WHEN ASKED ABOUT CONTROL SOLUTION AND TESTING THE METER AND STRIPS WITH CONTROL SOLUTION TO CHECK FOR ACCURACY, SHE STATED SHE DOES NOT HAVE CONTROL SOLUTION AND DOESN'T KNOW WHAT CONTROL SOLUTION IS. SHE INITIALLY DID NOT SEEK MEDICAL TREATMENT AND CONTINUED TO TEST WITH EACH METER AND TEST STRIPS AND CONTINUED TO RECEIVE LOW BLOOD GLUCOSE READINGS AND CONTINUED TO DRINK MORE ORANGE JUICE BASED ON THE LOW BLOOD GLUCOSE READINGS AND EVENTUALLY FELT SOMETHING WAS NOT RIGHT, HOWEVER SHE WAS NOT EXPERIENCING ANY SYMPTOMS, B

  Patient problems: Hyperglycemia

  MAUDE report 22780686 ↗
• InjuryAug 6, 2025Low Readings; Low Readings

  THE CUSTOMER REPORTED THAT TWO DIFFERENT METERS, A RELION PREMIER CLASSIC AND A RELION PREMIER VOICE, AND TWO DIFFERENT LOTS OF PREMIER TEST STRIPS ARE READING TOO LOW WHICH CAUSED HER TO BELIEVE THAT HER BLOOD SUGAR WAS TOO LOW, SO SHE DRANK ORANGE JUICE TO RAISE HER BLOOD GLUCOSE LEVELS AND ENDED UP GOING TO THE EMERGENCY ROOM TO BE TREATED. SHE STATED HER NORMAL BLOOD GLUCOSE LEVELS ARE 90-100; HOWEVER, SOMETIMES SHE RECEIVES LEVELS IN HIGHER HUNDREDS TO LOWER TWO HUNDREDS. SHE WAS RECEIVING RESULTS OF 50-60 TESTING WITH THESE PRODUCTS. WHEN ASKED ABOUT HAND CLEANSING, USING NEW LANCETS, AND BLOOD TESTING TECHNIQUES, SHE DESCRIBED PROPER BLOOD TESTING TECHNIQUES. WHEN ASKED ABOUT CONTROL SOLUTION AND TESTING THE METER AND STRIPS WITH CONTROL SOLUTION TO CHECK FOR ACCURACY, SHE STATED SHE DOES NOT HAVE CONTROL SOLUTION AND DOESN'T KNOW WHAT CONTROL SOLUTION IS. SHE INITIALLY DID NOT SEEK MEDICAL TREATMENT AND CONTINUED TO TEST WITH EACH METER AND TEST STRIPS AND CONTINUED TO RECEIVE LOW BLOOD GLUCOSE READINGS AND CONTINUED TO DRINK MORE ORANGE JUICE BASED ON THE LOW BLOOD GLUCOSE READINGS AND EVENTUALLY FELT SOMETHING WAS NOT RIGHT; HOWEVER, SHE WAS NOT EXPERIENCING ANY SYMPTOMS,

  Patient problems: Hyperglycemia

  MAUDE report 22729299 ↗
• InjuryNov 11, 2024High Readings; High Readings

  THE CUSTOMER STATES THAT SHE BELIEVES THE METER IS NOT WORKING PROPERLY BECAUSE SHE RECEIVED A HIGH READING, TREATED HERSELF, AND THEN STARTED FEELING ILL AND WENT TO THE EMERGENCY ROOM AND RECEIVED A MUCH LOWER READING WITH THEIR METER. THE CUSTOMER STATED THAT WITHIN TWO HOURS PRIOR TO THE INCIDENT, THE CUSTOMER AT A HALF A SANDWICH. THE CUSTOMER STATED SHE RECEIVED A READING OF 251. THE CUSTOMER STATED SHE TOOK FIVE UNITS OF INSULIN BASED ON THE READING OF 251. THE CUSTOMER STATED THAT SHE THEN STARTED TO FEEL WEIRD, SO SHE WENT TO THE EMERGENCY ROOM. AT THE EMERGENCY ROOM, WITH THEIR BLOOD GLUCOSE METER, THEY TESTED THE CUSTOMER AND RECEIVED A READING OF 41 INDICATING THE CUSTOMER'S BLOOD GLUCOSE WAS LOW. THEY GAVE HER GRAHAM CRACKERS AND APPLE JUICE TO BRING HER BLOOD SUGAR BACK UP. THE CUSTOMER HAS HAD HER METER FOR FOUR OR MORE YEARS AND STORES HER METER AND STRIPS IN THE BATHROOM. ADVISED CUSTOMER WE DON'T RECOMMEND STORING IN BATHROOM OR KITCHEN DUE TO HUMIDITY. THE CUSTOMER STATES SHE RECENTLY HAD VALLEY FEVER AND IS ON ANTIBIOTICS FOR THAT. THE CUSTOMER WASHES AND DRIES HANDS BEFORE TESTING, USES A NEW LANCET, DENIES ANY DAMAGE TO THE METER, AND OCCASIONALLY HAS TROUBLE

  Patient problems: Hypoglycemia

  MAUDE report 20650222 ↗
• InjuryNov 8, 2024High Readings; High Readings

  THE CUSTOMER STATES THAT SHE BELIEVES THE METER IS NOT WORKING PROPERLY BECAUSE SHE RECEIVED A HIGH READING, TREATED HERSELF, AND THEN STARTED FEELING ILL AND WENT TO THE EMERGENCY ROOM AND RECEIVED A MUCH LOWER READING WITH THEIR METER. THE CUSTOMER STATED THAT WITHIN TWO HOURS PRIOR TO THE INCIDENT, THE CUSTOMER ATE A HALF A SANDWICH. THE CUSTOMER STATED SHE RECEIVED A READING OF 251. THE CUSTOMER STATED SHE TOOK FIVE UNITS OF INSULIN BASED ON THE READING OF 251. THE CUSTOMER STATED THAT SHE THEN STARTED TO FEEL WEIRD, SO SHE WENT TO THE EMERGENCY ROOM. AT THE EMERGENCY ROOM, WITH THEIR BLOOD GLUCOSE METER, THEY TESTED THE CUSTOMER AND RECEIVED A READING OF 41 INDICATING THE CUSTOMER'S BLOOD GLUCOSE WAS LOW. THEY GAVE HER GRAHAM CRACKERS AND APPLE JUICE TO BRING HER BLOOD SUGAR BACK UP. THE CUSTOMER HAS HAD HER METER FOR FOUR OR MORE YEARS AND STORES HER METER AND STRIPS IN THE BATHROOM. ADVISED CUSTOMER WE DON'T RECOMMEND STORING IN BATHROOM OR KITCHEN DUE TO HUMIDITY. THE CUSTOMER STATES SHE RECENTLY HAD VALLEY FEVER AND IS ON ANTIBIOTICS FOR THAT. THE CUSTOMER WASHES AND DRIES HANDS BEFORE TESTING, USES A NEW LANCET, DENIES ANY DAMAGE TO THE METER, AND OCCASIONALLY HAS TROUBLE

  Patient problems: Hypoglycemia

  MAUDE report 20641133 ↗
• InjuryOct 21, 2024High Readings; High Readings

  THE CUSTOMER IS CALLING ON BEHALF OF HER HUSBAND. SHE STATED HE IS RECEIVING INACCURATE READINGS. SHE STATED SHE CALLED THE PARAMEDICS TWO WEEKS AGO WHEN READING ON THE METER WAS 381. CUSTOMER PURCHASED METER TWO WEEKS AGO. THE PATIENT'S WIFE STATED SHE WAS CONCERNED WITH HIS READING AND CALLED THE PARAMEDICS SINCE THE READING ON CLASSIC METER WAS 381 WHEN SHE TOOK IT AT 7:30 AM. WHEN THE PARAMEDICS ARRIVED, HE DID NOT HAVE TO TAKE ANY INSULIN DUE TO THE READING RECEIVED ON THEIR METER BEING 147. THE PARAMEDICS RECOMMENDED FOR METER TO BE CALIBRATED. NO TREATMENT WAS PROVIDED BY THE PARAMEDICS, THEY TESTED THE PATIENT AND LEFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20490543 ↗
• InjuryOct 18, 2024High Readings; High Readings

  THE CUSTOMER IS CALLING ON BEHALF OF HER HUSBAND. SHE STATED HE IS RECEIVING INACCURATE READINGS. SHE STATED SHE CALLED THE PARAMEDICS TWO WEEKS AGO WHEN READING ON THE METER WAS 381. CUSTOMER PURCHASED METER TWO WEEKS AGO. THE PATIENT'S WIFE STATED SHE WAS CONCERNED WITH HIS READING AND CALLED THE PARAMEDICS SINCE THE READING ON CLASSIC METER WAS 381 WHEN SHE TOOK IT AT 7:30 AM. WHEN THE PARAMEDICS ARRIVED, HE DID NOT HAVE TO TAKE ANY INSULIN DUE TO THE READING RECEIVED ON THEIR METER BEING 147. THE PARAMEDICS RECOMMENDED FOR METER TO BE CALIBRATED. NO TREATMENT WAS PROVIDED BY THE PARAMEDICS, THEY TESTED THE PATIENT AND LEFT. REPLACED METER, STRIPS, SENT CONTROL SOLUTION AND RETURN LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20487412 ↗
• InjuryJun 12, 2024Low Readings; Low Readings

  THE PATIENT STATED CLASSIC METER IS GIVING HER A READING THAT IS 35 POINTS LOWER THAN THE READING SHE RECEIVED AT THE HOSPITAL. THE PATIENT HAS NOT BEEN DIAGNOSED WITH DIABETES. THE PATIENT DESCRIBED WAKING UP AROUND 10 AM ON MAY 11, 2024, FEELING UNWELL AND EXPERIENCING SYMPTOMS SUCH AS SWEATING, FOGGINESS AND COLD. THE CALLER STATED SHE DID NOT CONSUME ANY FOOD, BEVERAGES, OR MEDICATION PRIOR TO THE INCIDENT SINCE SHE HAD JUST WOKEN UP. CUSTOMER STATED SHE DID FEEL LIKE HER SYMPTOMS MATCHED THE LOWER READING. THROUGHOUT THE DAY, SHE MONITORED HER BLOOD SUGAR LEVELS, NOTICING THEY REMAINED LOW. SHE STATED HER READINGS NORMALLY RANGE FROM 100-110 AND HER READING CAUSED CONCERN WHEN IT WAS READING AROUND 52 IN THE MORNING. SHE STATED SHE NOTIFIED HER SISTER WHO GAVE HER TWO GLASSES OF ORANGE JUICE. SHE CONTINUED TO CHECK HER BLOOD GLUCOSE EVERY 25 MINUTES AND THE READINGS REMAINED IN THE 50S. SHE DRANK MORE ORANGE JUICE, AND HER READING WENT UP TO 89. SHE STATED AFTER ONE HOUR THE READINGS DROPPED BACK TO THE 50S AND STAYED IN THE 50S THROUGHOUT THE DAY. THE PATIENT'S SISTER ATTEMPTED TO BRING HER BLOOD GLUCOSE UP THROUGHOUT THE DAY, BUT AROUND 11 PM, THE PATIENT'S BROTHER AND SISTE

  Patient problems: Dizziness; Shaking/Tremors

  MAUDE report 19525359 ↗
• InjuryJun 5, 2024Low Readings; Low Readings

  THE PATIENT STATED CLASSIC METER IS GIVING HER A READING THAT IS 35 POINTS LOWER THAN THE READING SHE RECEIVED AT THE HOSPITAL. THE PATIENT HAS NOT BEEN DIAGNOSED WITH DIABETES. THE PATIENT DESCRIBED WAKING UP AROUND 10 AM ON (B)(6) 2024, FEELING UNWELL AND EXPERIENCING SYMPTOMS SUCH AS SWEATING, FOGGINESS AND COLD. THE CALLER STATED SHE DID NOT CONSUME ANY FOOD, BEVERAGES, OR MEDICATION PRIOR TO THE INCIDENT SINCE SHE HAD JUST WOKEN UP. CUSTOMER STATED SHE DID FEEL LIKE HER SYMPTOMS MATCHED THE LOWER READING. THROUGHOUT THE DAY, SHE MONITORED HER BLOOD SUGAR LEVELS, NOTICING THEY REMAINED LOW. SHE STATED HER READINGS NORMALLY RANGE FROM 100-110 AND HER READING CAUSED CONCERN WHEN IT WAS READING AROUND 52 IN THE MORNING. SHE STATED SHE NOTIFIED HER SISTER WHO GAVE HER TWO GLASSES OF ORANGE JUICE. SHE CONTINUED TO CHECK HER BLOOD GLUCOSE EVERY 25 MINUTES AND THE READINGS REMAINED IN THE 50S. SHE DRANK MORE ORANGE JUICE, AND HER READING WENT UP TO 89. SHE STATED AFTER ONE HOUR THE READINGS DROPPED BACK TO THE 50S AND STAYED IN THE 50S THROUGHOUT THE DAY. THE PATIENT'S SISTER ATTEMPTED TO BRING HER BLOOD GLUCOSE UP THROUGHOUT THE DAY, BUT AROUND 11 PM, THE PATIENT'S BROTHER AND SISTER

  Patient problems: Dizziness; Hypoglycemia; Shaking/Tremors

  MAUDE report 19466231 ↗