ReliOn™ Premier Blood Glucose Test Strips 780025Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00681131285742), received between Sep 8, 2022 and Jun 5, 2023 — 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. How this data works · Data updated Oct 13, 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.

• InjuryJun 5, 2023Unable to Obtain Readings; High Readings; Unable to Obtain Readings; High Readings

  CUSTOMER CALLED BECAUSE YESTERDAY SHE HAD A DIABETIC SEIZURE. SHE WENT TO THE HOSPITAL, AND THEY SAID THE METER SHE HAS IS READING TOO HIGH. HER PROVIDER STATED IT CAUSED HER TO HAVE A DIABETIC SEIZURE. SHE SAID THAT THE METER WAS READING HIGH, BUT HER BLOOD GLUCOSE WAS ACTUALLY LOW. SHE EXPLAINED SHE TOOK A READING AT NIGHT AROUND 9:09 PM ON THE CLASSIC METER AND RECEIVED 138. SHE DOSED HERSELF WITH INSULIN BASED ON THE READING OF 138. SHE WENT TO SLEEP. SHE DID NOT EXPERIENCE ANY SYMPTOMS AT THE TIME. THE NEXT MORNING, SHE WOKE UP AND THEN CHECKED HER BLOOD SUGAR AT 8:00 AM AND SHE DID NOT RECEIVE A READING, THE METER SCREEN ONLY DISPLAYED THREE DASHES ON THE SCREEN. SHE THEN STARTED TO HAVE A SEIZURE THEN BECAME INCOHERENT. HER MOTHER THEN ATTEMPTED TO ASSIST HER DAUGHTER BY PERFORMING A BLOOD TEST USING THE RELION PREMIER CLASSIC METER BUT COULDN'T RECEIVE A READING. SHE CONTACTED THE PARAMEDICS. AFTER THE AMBULANCE ARRIVED, THEY CHECKED HER BLOOD SUGAR USING THEIR METER AND THEY RECEIVED A READING OF 29. THE PARAMEDICS TREATED HER WITH GLUCAGON AND TWO GLUCOSE GEL PACKS. REPLACED METER, STRIPS, SENT CONTROL SOLUTION AND RETURN LABEL.

  Patient problems: Convulsion/Seizure; Hypoglycemia

  MAUDE report 17058337 ↗
• InjuryMay 24, 2023Unable to Obtain Readings; High Readings; Unable to Obtain Readings; High Readings

  CUSTOMER CALLED BECAUSE YESTERDAY SHE HAD A DIABETIC SEIZURE. SHE WENT TO THE HOSPITAL, AND THEY SAID THE METER SHE HAS IS READING TOO HIGH. HER PROVIDER STATED IT CAUSED HER TO HAVE A DIABETIC SEIZURE. SHE SAID THAT THE METER WAS READING HIGH, BUT HER BLOOD GLUCOSE WAS ACTUALLY LOW. SHE EXPLAINED SHE TOOK A READING AT NIGHT AROUND 9:09 PM ON THE CLASSIC METER AND RECEIVED 138. SHE DOSED HERSELF WITH INSULIN BASED ON THE READING OF 138. SHE WENT TO SLEEP. SHE DID NOT EXPERIENCE ANY SYMPTOMS AT THE TIME. THE NEXT MORNING, SHE WOKE UP AND THEN CHECKED HER BLOOD SUGAR AT 8:00 AM AND SHE DID NOT RECEIVE A READING, THE METER SCREEN ONLY DISPLAYED THREE DASHES ON THE SCREEN. SHE THEN STARTED TO HAVE A SEIZURE THEN BECAME INCOHERENT. HER MOTHER THEN ATTEMPTED TO ASSIST HER DAUGHTER BY PERFORMING A BLOOD TEST USING THE RELION PREMIER CLASSIC METER BUT COULDN'T RECEIVE A READING. SHE CONTACTED THE PARAMEDICS. AFTER THE AMBULANCE ARRIVED, THEY CHECKED HER BLOOD SUGAR USING THEIR METER AND THEY RECEIVED A READING OF 29. THE PARAMEDICS TREATED HER WITH GLUCAGON AND TWO GLUCOSE GEL PACKS. REPLACED METER, STRIPS, SENT CONTROL SOLUTION AND RETURN LABEL.

  Patient problems: Convulsion/Seizure; Hypoglycemia

  MAUDE report 16991706 ↗
• InjuryNov 1, 2022High Readings; High Readings

  CUSTOMER CALLED BECAUSE HE'S HAD THE METER FOR TWO MONTHS AND THE METER READS 40-50 POINTS OFF, READING TOO HIGH. HE USES IT SEVERAL TIMES A DAY. HE SAID THAT HE WOULD READ HIGH WITH THE CLASSIC, THEN TAKE INSULIN, BUT HIS SUGAR WOULD DROP, AND IT WOULD BE LOW. CUSTOMER STATED HE WOULD HAVE SYMPTOMS OF LOW BLOOD SUGAR, SUCH AS DIZZINESS AND LACK OF COORDINATION. HE SAID FOR EXAMPLE, BUT THESE AREN'T THE ACTUAL NUMBERS, THAT HIS READING WOULD BE 110 WITH THE CLASSIC, BUT THEN HIS ACTUAL BLOOD GLUCOSE WOULD BE 60 WHEN TESTING WITH ANOTHER METER. CUSTOMER STORES METER AND STRIPS IN UTILITY DRAWER IN THE KITCHEN. CUSTOMER DOESN'T HAVE TROUBLE GETTING SAMPLE OF BLOOD. CUSTOMER CHANGES LANCETS EVERY TIME HE TESTS. TYPE 1 DIABETIC. CUSTOMER WASHES HANDS WITH SOAP AND WATER AND ALLOWS HANDS TO DRY THOROUGHLY. CUSTOMER CHANGES LANCETS MOST OF THE TIME UNLESS HE'S IN A HURRY. CUSTOMER HAS NOT CONTACTED THE PARAMEDICS, NOR DID HE GO TO THE ER. HE ADJUSTED HIS GLUCOSE WITH SUGARY DRINKS AND FOOD. WALKED CUSTOMER THROUGH THE MEMORY AND HAD READINGS OF 56 ON (B)(6) 2022 AT 6:21 PM; 65 ON (B)(6) 2022 AT 5:52 PM; 72 ON (B)(6) 2022 AT 5:41 PM; 301 ON (B)(6) 2022 AT 2:48 AM; 46 ON (B)(6) 2022 AT 6:5

  Patient problems: Hypoglycemia

  MAUDE report 15712793 ↗
• InjuryOct 25, 2022Low Readings; Low Readings

  CUSTOMER SAYS METER WILL SOMETIMES WORK AND SOMETIMES NOT WORK. SHE SAID IT WILL GIVE ER1 OR ER2 AND SOMETIMES READ LOW. ON (B)(6) 2022, SHE SAID HER HUSBAND HAD TAKEN A READING WITH THE METER AND RECEIVED A READING OF 32. THE AMBULANCE WAS CALLED AND WITH THEIR METER IT READ 140. I ASKED WHEN THE AMBULANCE CAME, AND SHE SAID RIGHT AFTER HE GOT THE READING OF 32, SHE CALLED THEM. THEY CAME AND TOOK HIS BLOOD WHICH READ 140. I EXPLAINED TO THE CUSTOMER THAT BECAUSE THE AMBULANCE WAS CALLED, WE WILL NEED TO REPLACE THE METER AND STRIPS, AS WELL AS FILL OUT AN INCIDENT REPORT, I EXPLAINED I WILL ASK A COUPLE OF QUESTIONS AND IF SHE COULD ANSWER THEM TO THE BEST THAT SHE CAN, THAT WOULD BE BEST. SHE AGREED. HER HUSBAND'S INITIALS ARE (B)(6). HER HUSBAND IS 72 YEARS OLD. HER HUSBAND'S DATE OF BIRTH IS (B)(6). HER HUSBAND IS NOT ON INSULIN. HER HUSBAND IS ON METFORMIN AND WATER PILLS. NO CHANGES TO DIET EXERCISE MEDICATION OR STRESS. HER HUSBAND USED TO BE ON OXYGEN THERAPY IN THE PAST, BUT NOT RECENTLY. PATIENT WASHES AND DRIES HIS HANDS WITH SOAP AND WATER BEFORE LANCING. PATIENT USES HIS FINGERTIP FOR TESTING. PATIENT DOES NOT HAVE TROUBLE GETTING A SAMPLE OF BLOOD. PATIENT USES THE C

  Patient problems: Dehydration

  MAUDE report 15664808 ↗
• InjuryOct 13, 2022Low Readings; Low Readings

  CUSTOMER SAYS METER WILL SOMETIMES WORK AND SOMETIMES NOT WORK. SHE SAID IT WILL GIVE ER1 OR ER2 AND SOMETIMES READ LOW. ON (B)(6) 2022, SHE SAID HER HUSBAND HAD TAKEN A READING WITH THE METER AND RECEIVED A READING OF 32. THE AMBULANCE WAS CALLED AND WITH THEIR METER IT READ 140. I ASKED WHEN THE AMBULANCE CAME, AND SHE SAID RIGHT AFTER HE GOT THE READING OF 32, SHE CALLED THEM. THEY CAME AND TOOK HIS BLOOD WHICH READ 140. I EXPLAINED TO THE CUSTOMER THAT BECAUSE THE AMBULANCE WAS CALLED, WE WILL NEED TO REPLACE THE METER AND STRIPS, AS WELL AS FILL OUT AN INCIDENT REPORT, I EXPLAINED I WILL ASK A COUPLE OF QUESTIONS AND IF SHE COULD ANSWER THEM TO THE BEST THAT SHE CAN, THAT WOULD BE BEST. SHE AGREED. HER HUSBAND'S INITIALS ARE (B)(6). HER HUSBAND IS 72 YEARS OLD. HER HUSBAND'S DATE OF BIRTH IS (B)(6) 1951. HER HUSBAND IS NOT ON INSULIN. HER HUSBAND IS ON METFORMIN AND WATER PILLS. NO CHANGES TO DIET EXERCISE MEDICATION OR STRESS. HER HUSBAND USED TO BE ON OXYGEN THERAPY IN THE PAST, BUT NOT RECENTLY. PATIENT WASHES AND DRIES HIS HANDS WITH SOAP AND WATER BEFORE LANCING. PATIENT USES HIS FINGERTIP FOR TESTING. PATIENT DOES NOT HAVE TROUBLE GETTING A SAMPLE OF BLOOD. PATIENT USES

  Patient problems: Dehydration

  MAUDE report 15595171 ↗
• InjurySep 29, 2022High Readings; High Readings

  CUSTOMER CALLED BECAUSE HE'S HAD THE METER FOR TWO MONTHS AND THE METER READS 40-50 POINTS OFF, READING TOO HIGH. HE USES IT SEVERAL TIMES A DAY. HE SAID THAT HE WOULD READ HIGH WITH THE CLASSIC, THEN TAKE INSULIN, BUT HIS SUGAR WOULD DROP, AND IT WOULD BE LOW. CUSTOMER STATED HE WOULD HAVE SYMPTOMS OF LOW BLOOD SUGAR, SUCH AS DIZZINESS AND LACK OF COORDINATION. HE SAID FOR EXAMPLE, BUT THESE AREN'T THE ACTUAL NUMBERS, THAT HIS READING WOULD BE 110 WITH THE CLASSIC, BUT THEN HIS ACTUAL BLOOD GLUCOSE WOULD BE 60 WHEN TESTING WITH ANOTHER METER. CUSTOMER STORES METER AND STRIPS IN UTILITY DRAWER IN THE KITCHEN. CUSTOMER DOESN'T HAVE TROUBLE GETTING SAMPLE OF BLOOD. CUSTOMER CHANGES LANCETS EVERY TIME HE TESTS. TYPE 1 DIABETIC. CUSTOMER WASHES HANDS WITH SOAP AND WATER AND ALLOWS HANDS TO DRY THOROUGHLY. CUSTOMER CHANGES LANCETS MOST OF THE TIME UNLESS HE'S IN A HURRY. CUSTOMER HAS NOT CONTACTED THE PARAMEDICS, NOR DID HE GO TO THE ER. HE ADJUSTED HIS GLUCOSE WITH SUGARY DRINKS AND FOOD. WALKED CUSTOMER THROUGH THE MEMORY AND HAD READINGS OF 56 ON (B)(6) 2022 AT 6:21 PM; 65 ON (B)(6) 2022 AT 5:52 PM; 72 ON (B)(6) 2022 AT 5:41 PM; 301 ON (B)(6) 2022 AT 2:48 AM; 46 ON (B)(6) 2022 AT 6:5

  Patient problems: Hypoglycemia

  MAUDE report 15506024 ↗
• InjurySep 22, 2022Incorrect Measurement; Incorrect Measurement

  CUSTOMER STATED SHE WAS LEAVING AN EVENT YESTERDAY AND AS SHE STARTED WALKING TOWARDS HER CAR, SHE STARTED HAVING A SEIZURE. SHE STATED THAT SHE DIDN'T FEEL LOW AND THE METER THAT SHE HAS READ 90 AND SO MEDICALLY SHE SHOULDN'T HAVE BEEN HAVING A LOW BLOOD GLUCOSE SEIZURE, BUT SHE DID. CUSTOMER STATED HER DOCTOR SAID UNLESS IT WAS SOMETHING UNDIAGNOSED THAT WOULD BE THE ONLY THING THAT WOULD HAVE CAUSED IT, SO THEY MADE ADJUSTMENTS, AND EVERYTHING SEEMED TO BALANCE OUT AND WAS STILL GOOD THIS MORNING SO SHE WAS DRIVING HOME AND SHE STOPPED TO GET GAS AND STARTED HAVING ANOTHER SEIZURE AND THE METER READ 72 AND SHE STATED AGAIN THAT IS NOT LOW ENOUGH TO CAUSE A DIABETIC SEIZURE. ANOTHER CONCERN OF HERS YESTERDAY WAS THAT SHE STATED AFTER HAVING OVER 100 GRAMS OF CARBOHYDRATES, ABOUT 30 MINUTES AFTER THE READING OF 90, SHE STILL WAS TESTING AT ONLY 98 AND THAT IS A LOT OF CARBS AND SHE FEELS LIKE IT SHOULD HAVE BEEN HIGHER, AND THEN EVEN ANOTHER 30 MINUTES LATER, IT WAS STILL ONLY AT 108. CALLER STATED SHE IS FEELING FINE NOW BUT SHE HAS CONCERNS THAT THERE IS SOMETHING WRONG WITH THE METER AND/OR STRIPS AND SHE CAN'T TRUST THE METER SHE HAS NOW. CALLER STATED SHE HAD HAD THIS SAME TH

  Patient problems: Hyperglycemia

  MAUDE report 15468614 ↗
• InjurySep 8, 2022Low Readings; Low Readings

  CUSTOMER STATED SHE WAS LEAVING AN EVENT YESTERDAY AND AS SHE STARTED WALKING TOWARDS HER CAR, SHE STARTED HAVING A SEIZURE. SHE STATED THAT SHE DIDN'T FEEL LOW AND THE METER THAT SHE HAS READ 90 AND SO MEDICALLY SHE SHOULDN'T HAVE BEEN HAVING A LOW BLOOD GLUCOSE SEIZURE, BUT SHE DID. CUSTOMER STATED HER DOCTOR SAID UNLESS IT WAS SOMETHING UNDIAGNOSED THAT WOULD BE THE ONLY THING THAT WOULD HAVE CAUSED IT, SO THEY MADE ADJUSTMENTS, AND EVERYTHING SEEMED TO BALANCE OUT AND WAS STILL GOOD THIS MORNING SO SHE WAS DRIVING HOME AND SHE STOPPED TO GET GAS AND STARTED HAVING ANOTHER SEIZURE AND THE METER READ 72 AND SHE STATED AGAIN THAT IS NOT LOW ENOUGH TO CAUSE A DIABETIC SEIZURE. ANOTHER CONCERN OF HERS YESTERDAY WAS THAT SHE STATED AFTER HAVING OVER 100 GRAMS OF CARBOHYDRATES, ABOUT 30 MINUTES AFTER THE READING OF 90, SHE STILL WAS TESTING AT ONLY 98 AND THAT IS A LOT OF CARBS AND SHE FEELS LIKE IT SHOULD HAVE BEEN HIGHER, AND THEN EVEN ANOTHER 30 MINUTES LATER, IT WAS STILL ONLY AT 108. CALLER STATED SHE IS FEELING FINE NOW BUT SHE HAS CONCERNS THAT THERE IS SOMETHING WRONG WITH THE METER AND/OR STRIPS AND SHE CAN'T TRUST THE METER SHE HAS NOW. CALLER STATED SHE HAD HAD THIS SAME TH

  Patient problems: Convulsion/Seizure

  MAUDE report 15382379 ↗