ReliOn™ Premier Voice Basic Meter 780001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00681131169851), received between Aug 6, 2025 and Aug 11, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Low Readings” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 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 22768827 ↗
• 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 22727538 ↗