ReliOn™ Premier Blood Glucose Test Strips 780050 / 780100Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00681131169776), received between Nov 14, 2018 and Feb 21, 2024 — classified as 19 injuries, 10 malfunctions.

The most frequently reported specific device problem is “High Readings” (15 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2024High Readings; High Readings

  F069321K6470. LOT UL12BBEHE - 2024-08-11 - 100CT. THE PATIENT IS RECEIVING HIGH READINGS. THE PATIENT HAS HAD METER FOR ABOUT THREE MONTHS AND HAS JUST RECENTLY HAD AN ISSUE WITH IT. THE PATIENT WAS TAKEN TO THE HOSPITAL BECAUSE OF THE READINGS, AND THEY DID A BLOOD DRAW. THE PATIENT HAS NOT DONE A CONTROL SOLUTION TEST AND WALMART DID NOT OFFER CONTROL SOLUTION AND CALLER WAS NOT AWARE. THE CALLER IS CONTACTING US ON BEHALF OF THE PATIENT. THE PATIENT KEEPS STRIPS IN THE ORIGINAL BOTTLE. THE PATIENT KEEPS METER AND TEST STRIPS IN BEDROOM AWAY FROM HUMIDITY AND DIRECT SUNLIGHT. THE LAST FIVE READINGS ARE 301, 427 AT 6 AM, 245 LAST NIGHT, 354 DURING DAY YESTERDAY, AND 422 YESTERDAY SOMETIME. THIS METER DOES NOT RECORD THE DATE AND TIMES OF THE EXACT READINGS, SO I WAS NOT ABLE TO GET THEM. THE PATIENT IS NOT ON OXYGEN THERAPY. THE PATIENT KEEPS STRIPS IN THE ORIGINAL BOTTLE AND THE LID CLOSED AT ALL TIMES. THE PATIENT HAS NO DIFFICULTY GETTING A BLOOD SAMPLE. THE PATIENT CHANGES LANCETS EVERYDAY BUT NOT ALWAYS BEFORE EACH TEST. THE PATIENT TESTS ON FINGERTIPS ONLY AND USES AN ALCOHOL WIPE BEFORE EACH TEST. THE PATIENT USES THE SECOND DROP OF BLOOD. TODAY THE READING WAS IN THE 400'S

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754862 ↗
• InjuryFeb 14, 2024High Readings; High Readings

  (B)(6). LOT UL12BBEHE - 2024-08-11 - (B)(4). THE PATIENT IS RECEIVING HIGH READINGS. THE PATIENT HAS HAD METER FOR ABOUT THREE MONTHS AND HAS JUST RECENTLY HAD AN ISSUE WITH IT. THE PATIENT WAS TAKEN TO THE HOSPITAL BECAUSE OF THE READINGS, AND THEY DID A BLOOD DRAW. THE PATIENT HAS NOT DONE A CONTROL SOLUTION TEST AND WALMART DID NOT OFFER CONTROL SOLUTION AND CALLER WAS NOT AWARE. THE CALLER IS CONTACTING US ON BEHALF OF THE PATIENT. THE PATIENT KEEPS STRIPS IN THE ORIGINAL BOTTLE. THE PATIENT KEEPS METER AND TEST STRIPS IN BEDROOM AWAY FROM HUMIDITY AND DIRECT SUNLIGHT. THE LAST FIVE READINGS ARE 301, 427 AT 6 AM, 245 LAST NIGHT, 354 DURING DAY YESTERDAY, AND 422 YESTERDAY SOMETIME. THIS METER DOES NOT RECORD THE DATE AND TIMES OF THE EXACT READINGS, SO I WAS NOT ABLE TO GET THEM. THE PATIENT IS NOT ON OXYGEN THERAPY. THE PATIENT KEEPS STRIPS IN THE ORIGINAL BOTTLE AND THE LID CLOSED AT ALL TIMES. THE PATIENT HAS NO DIFFICULTY GETTING A BLOOD SAMPLE. THE PATIENT CHANGES LANCETS EVERYDAY BUT NOT ALWAYS BEFORE EACH TEST. THE PATIENT TESTS ON FINGERTIPS ONLY AND USES AN ALCOHOL WIPE BEFORE EACH TEST. THE PATIENT USES THE SECOND DROP OF BLOOD. TODAY THE READING WAS IN THE 400'S AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18704740 ↗
• MalfunctionFeb 14, 2024High Readings; High Readings

  (B)(6). LOT WL11BBAJA - 2025-08-01 - 100CT. CALLER HAS A DEXCOM, AND THE CLASSIC METER IS READING HIGH COMPARED TO THE DEXCOM AND HER TRU METRIX METER THAT SHE HAS. CALLER RECEIVED A READING ON CLASSIC ON (B)(6) 2024 AT 12:53 PM AND THE READING WAS 359, AND SHE RECEIVED A READING ON TRU METRIX ON (B)(6) 2024 AT 12:55 PM AND IT WAS 71. CUSTOMER DID NOT REPORT ANY ADVERSE EVENT ISSUES FROM THESE READINGS. CALLER DID NOT GIVE ANY RESULT EXAMPLES FROM THE DEXCOM. THE COMPARED READINGS OF 359 AND 71 ARE OUTSIDE ZONES A & B AND THIS WOULD BE CONSIDERED A MALFUNCTION AND REPORTABLE. REPLACED METER, STRIPS, SENT CONTROL SOLUTION AND SENT RETURN LABEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18700731 ↗
• InjuryJan 9, 2024High Readings; High Readings

  (B)(6). LOT EB4031102 - 2025-05-02 - (B)(4). THE CUSTOMER REPORTED RECEIVING VARIABLE READINGS. THE CUSTOMER TESTED LAST NIGHT, AND THE FIRST TEST WAS HIGH, AND THE SECOND TEST ONE HOUR LATER WAS LOW. HE DID NOT TAKE ANY INSULIN. CUSTOMER REPORTED THAT ON (B)(6) 2023, HIS BLOOD SUGAR READ HIGH AT 440. HE TOOK THE AMOUNT OF INSULIN THAT WAS RECOMMENDED, (B)(4) OF GLARGINE AND (B)(4) OF NOVOLOG, HIS WIFE WAS WITH HIM AND HEARD HIM MOANING. HE ROLLED OUT OF BED ON THE FLOOR. HIS WIFE CALLED THE PARAMEDICS. HE WAS PASSED OUT WHEN THEY ARRIVED. THE CUSTOMER PASSED OUT FOR ABOUT AN HOUR. THE PARAMEDICS CHECKED HIS GLUCOSE, AND IT WAS 39. THEY TREATED HIM WITH MEDS, BUT HE HAS NO IDEA WHAT THEY GAVE. THEY TREATED HIM AT HOME. HE WOKE UP AND TOLD THEM HE DID NOT WANT TO GO TO THE HOSPITAL. BEFORE THEY LEFT, THEY TOOK HIS BLOOD SUGAR, AND IT WAS 140. HE SAID THEY CHECKED IT THREE OR FOUR TIMES AS IT WAS GRADUALLY GETTING BETTER. IT WENT FROM 80 TO 140. HE SAID HE DOESN'T KNOW IF THE PROBLEM IS WITH THE METER OR HIM. HE ALSO MENTIONED HE TOOK A BLOOD TEST LAST NIGHT AND THAT RESULT WAS 364. HE DID NOT TAKE INSULIN. TWO HOURS LATER, WITHOUT TAKING INSULIN OR MEDICATION, HE STOOD UP AND HE FEL

  Patient problems: Syncope/Fainting

  MAUDE report 18472652 ↗
• InjuryJan 4, 2024High Readings; High Readings

  (B)(6). LOT EB4031102 - (B)(6) 2025 - 50CT. THE CUSTOMER REPORTED RECEIVING VARIABLE READINGS. THE CUSTOMER TESTED LAST NIGHT, AND THE FIRST TEST WAS HIGH, AND THE SECOND TEST ONE HOUR LATER WAS LOW. HE DID NOT TAKE ANY INSULIN. CUSTOMER REPORTED THAT ON 11/29/2023, HIS BLOOD SUGAR READ HIGH AT 440. HE TOOK THE AMOUNT OF INSULIN THAT WAS RECOMMENDED, 10 UNITS OF GLARGINE AND 10 UNITS OF NOVOLOG, HIS WIFE WAS WITH HIM AND HEARD HIM MOANING. HE ROLLED OUT OF BED ON THE FLOOR. HIS WIFE CALLED THE PARAMEDICS. HE WAS PASSED OUT WHEN THEY ARRIVED. THE CUSTOMER PASSED OUT FOR ABOUT AN HOUR. THE PARAMEDICS CHECKED HIS GLUCOSE, AND IT WAS 39. THEY TREATED HIM WITH MEDS, BUT HE HAS NO IDEA WHAT THEY GAVE. THEY TREATED HIM AT HOME. HE WOKE UP AND TOLD THEM HE DID NOT WANT TO GO TO THE HOSPITAL. BEFORE THEY LEFT, THEY TOOK HIS BLOOD SUGAR, AND IT WAS 140. HE SAID THEY CHECKED IT THREE OR FOUR TIMES AS IT WAS GRADUALLY GETTING BETTER. IT WENT FROM 80 TO 140. HE SAID HE DOESN'T KNOW IF THE PROBLEM IS WITH THE METER OR HIM. HE ALSO MENTIONED HE TOOK A BLOOD TEST LAST NIGHT AND THAT RESULT WAS 364. HE DID NOT TAKE INSULIN. TWO HOURS LATER, WITHOUT TAKING INSULIN OR MEDICATION, HE STOOD UP AND HE F

  Patient problems: Syncope/Fainting

  MAUDE report 18443001 ↗
• InjuryJul 5, 2023High Readings; High Readings

  CALLER STATED THAT METER HAD BEEN GIVING INCORRECT READINGS AND NOTED THAT THE READINGS APPEARED TO BE OF A NORMAL LEVEL, SO THE PATIENT CONTINUED WITH HIS NORMAL ROUTINE. ON THE DAY OF THE INCIDENT, THE PATIENT WAS EXHIBITING SYMPTOMS OF LOW BLOOD SUGAR, SO 911 WAS CALLED. BECAUSE HE WAS LOW, HE ATE SOME SWEET FOODS BEFORE THE PARAMEDICS ARRIVED TO GET HIS BLOOD SUGAR BACK UP. THE PARAMEDICS CHECKED HIS LEVELS WITH A BLOOD GLUCOSE TEST, AND THEY RECEIVED A READING OF 79 WITH THEIR METER, BUT THE CLASSIC METER READ 115. CHECKED GLUCOSE READINGS AGAIN IN THE AMBULANCE AND THEY GAVE HIM A GLUCOSE DRINK TO GET HIS BLOOD GLUCOSE LEVEL BACK UP. THE AMBULANCE TOOK HIM TO THE HOSPITAL FOR FURTHER TREATMENT. THEY DID LAB WORK AT THE HOSPITAL. HE ENDED UP VOMITING AT THE HOSPITAL AND RECEIVED FURTHER TREATMENT UNTIL HE WAS STABLE ENOUGH TO GO HOME. REPLACED METER, STRIPS, SENT CONTROL SOLUTION AND RETURN LABEL.

  Patient problems: Chills; Diaphoresis; Headache; Hypoglycemia; Vomiting

  MAUDE report 17263045 ↗
• InjuryJul 3, 2023High Readings; High Readings

  CVP10V00397. METER WAS PURCHASED IN (B)(6) 2022. LOT UN28BBRHF - (B)(6) 2024 - 100CT. CALLER STATED THAT METER HAD BEEN GIVING INCORRECT READINGS AND NOTED THAT THE READINGS APPEARED TO BE OF A NORMAL LEVEL, SO THE PATIENT CONTINUED WITH HIS NORMAL ROUTINE. ON THE DAY OF THE INCIDENT, THE PATIENT WAS EXHIBITING SYMPTOMS OF LOW BLOOD SUGAR, SO 911 WAS CALLED. BECAUSE HE WAS LOW, HE ATE SOME SWEET FOODS BEFORE THE PARAMEDICS ARRIVED TO GET HIS BLOOD SUGAR BACK UP. THE PARAMEDICS CHECKED HIS LEVELS WITH A BLOOD GLUCOSE TEST, AND THEY RECEIVED A READING OF 79 WITH THEIR METER, BUT THE CLASSIC METER READ 115. CHECKED GLUCOSE READINGS AGAIN IN THE AMBULANCE AND THEY GAVE HIM A GLUCOSE DRINK TO GET HIS BLOOD GLUCOSE LEVEL BACK UP. THE AMBULANCE TOOK HIM TO THE HOSPITAL FOR FURTHER TREATMENT. THEY DID LAB WORK AT THE HOSPITAL. HE ENDED UP VOMITING AT THE HOSPITAL AND RECEIVED FURTHER TREATMENT UNTIL HE WAS STABLE ENOUGH TO GO HOME. REPLACED METER, STRIPS, SENT CONTROL SOLUTION AND RETURN LABEL.

  Patient problems: Chills; Diaphoresis; Headache; Hypoglycemia; Vomiting

  MAUDE report 17246126 ↗
• InjuryJun 1, 2023High Readings; High Readings

  EVENT DATE: (B)(6)2023. AWARE DATE: (B)(6)2023. METER IS ABOUT ONE YEAR OLD. CALLER FEELS THAT THE METER IS GIVING HIGH READINGS. CUSTOMER STATED SHE TESTED AT HOME WITH THE PREMIER CLASSIC METER AND RECEIVED A READING OF 356. SHE WASN'T SURE IF THIS WAS CORRECT, AND SHE FELT "WEIRD", SO HER SISTER TOOK HER TO THE EMERGENCY ROOM, AND THEY TESTED HER WITH THEIR METER AND RECEIVED A READING OF 190. CUSTOMER REPORTED THE FOLLOWING READINGS IN HER METER MEMORY. 222 - (B)(6)2023 AT 1:01 PM; 258 - (B)(6)2023 AT 12:47 PM; 269 - (B)(6)2023 AT 10:21 PM. CALLER ACKNOWLEDGED THAT THE DATE AND TIME ARE OFF ON THE METER. CUSTOMER COULD NOT FIND THE READING OF 356 IN HER METER MEMORY DURING THE CALL. CUSTOMER DID NOT TREAT HERSELF BASED ON THE READING 356 AND WASN'T SURE IF IT WAS CORRECT, SO THAT IS WHY HER SISTER TOOK HER TO THE EMERGENCY ROOM. THE ONLY TREATMENT THE EMERGENCY ROOM PROVIDED HER WITH WAS THAT THEY GAVE HER FLUIDS AND DISCHARGED HER. CUSTOMER STATES THAT WHEN SHE GOT HOME FROM THE ER, ABOUT 3-5 MINUTES' DRIVE TIME LATER, SHE TESTED AGAIN WITH HER METER AND 352, AND THIS IS ALSO UNVERIFIABLE DUE TO THE DATE AND TIME BEING OFF IN THE METER AND CUSTOMER NOT BEING ABLE TO FIND IT IN

  Patient problems: Malaise

  MAUDE report 17044810 ↗
• InjuryMay 22, 2023High Readings; High Readings

  EVENT DATE: (B)(6) 2023. AWARE DATE: (B)(6) 2023. METER IS ABOUT ONE YEAR OLD. CALLER FEELS THAT THE METER IS GIVING HIGH READINGS. CUSTOMER STATED SHE TESTED AT HOME WITH THE PREMIER CLASSIC METER AND RECEIVED A READING OF 356. SHE WASN'T SURE IF THIS WAS CORRECT, AND SHE FELT "WEIRD", SO HER SISTER TOOK HER TO THE ER, AND THEY TESTED HER WITH THEIR METER AND RECEIVED A READING OF 190. CUSTOMER REPORTED THE FOLLOWING READINGS IN HER METER MEMORY. 222 - (B)(6) 2023 AT 1:01 PM; 258 - (B)(6) 2023 AT 12:47 PM; 269 - 4/4/2023 AT 10:21 PM. CALLER ACKNOWLEDGED THAT THE DATE AND TIME ARE OFF ON THE METER. CUSTOMER COULD NOT FIND THE READING OF 356 IN HER METER MEMORY DURING THE CALL. CUSTOMER DID NOT TREAT HERSELF BASED ON THE READING 356 AND WASN'T SURE IF IT WAS CORRECT, SO THAT IS WHY HER SISTER TOOK HER TO THE ER. THE ONLY TREATMENT THE ER PROVIDED HER WITH WAS THAT THEY GAVE HER FLUIDS AND DISCHARGED HER. CUSTOMER STATES THAT WHEN SHE GOT HOME FROM THE ER, ABOUT 3-5 MINUTES' DRIVE TIME LATER, SHE TESTED AGAIN WITH HER METER AND 352, AND THIS IS ALSO UNVERIFIABLE DUE TO THE DATE AND TIME BEING OFF IN THE METER AND CUSTOMER NOT BEING ABLE TO FIND IT IN THE METER MEMORY. CUSTOMER DOESN'

  Patient problems: Malaise

  MAUDE report 16974508 ↗
• InjuryApr 13, 2023High Readings; High Readings

  METER IS BRAND NEW. CALLER STATED THEY RECEIVED A READING OF 107 AND THE PARAMEDICS RECEIVED A READING OF 25. CALLER STATED WITHIN THE LAST MONTH, RODNEY (PATIENT) HAS BEEN HAVING A LOT OF TROUBLES RECENTLY WITH HIS BLOOD SUGAR AND DIABETES. WHEN SHE TESTED HIM, THE METER READ 107, WHICH SHE STATED IS A PRETTY GOOD READING, SO SHE DIDN'T THINK HE HAD LOW BLOOD SUGAR, BUT THEN HE STARTED GETTING REALLY COMBATIVE, SO SHE CALLED THE PARAMEDICS, AND WHEN THEY GOT THERE, SHE TOLD THEM THE METER READ 107, BUT WHEN THEY TESTED HIM WITH THEIR METER, IT READ 25, INDICATING HE WAS INDEED HAVING LOW BLOOD SUGAR. CALLER STATED THAT PATIENT OFTEN RUNS HIGH ON THEIR BLOOD GLUCOSE. CALLER WAS UNSURE IF THE PATIENT ATE OR DRANK ANYTHING BEFORE THE INCIDENT AND SHE STATED HE PROBABLY DRANK SOMETHING, BUT HE DIDN'T EAT ANYTHING. CALLER STATED SHE DID NOT TREAT THE PATIENT BASED ON THE READING OF 107 RECEIVED ON THE PREMIER VOICE METER BECAUSE SHE DID NOT WANT TO GIVE HIM ANYTHING BECAUSE SHE WASN'T SURE WHAT HIS BLOOD GLUCOSE ACTUALLY WAS. THAT IS WHEN SHE CALLED THE PARAMEDICS. CALLER STATED THE PATIENT WAS TRANSFERRED TO GOOD SAMARITAN HOSPITAL IN KEARNEY, NE. CALLER STATED INCIDENT HAPPENED EARLY

  Patient problems: Dizziness; Hypoglycemia

  MAUDE report 16730154 ↗
• InjuryApr 11, 2023High Readings; High Readings

  METER IS BRAND NEW. CALLER STATED THEY RECEIVED A READING OF 107 AND THE PARAMEDICS RECEIVED A READING OF 25. CALLER STATED WITHIN THE LAST MONTH, RODNEY (PATIENT) HAS BEEN HAVING A LOT OF TROUBLES RECENTLY WITH HIS BLOOD SUGAR AND DIABETES. WHEN SHE TESTED HIM, THE METER READ 107, WHICH SHE STATED IS A PRETTY GOOD READING, SO SHE DIDN'T THINK HE HAD LOW BLOOD SUGAR, BUT THEN HE STARTED GETTING REALLY COMBATIVE, SO SHE CALLED THE PARAMEDICS, AND WHEN THEY GOT THERE, SHE TOLD THEM THE METER READ 107, BUT WHEN THEY TESTED HIM WITH THEIR METER, IT READ 25, INDICATING HE WAS INDEED HAVING LOW BLOOD SUGAR. CALLER STATED THAT PATIENT OFTEN RUNS HIGH ON THEIR BLOOD GLUCOSE. CALLER WAS UNSURE IF THE PATIENT ATE OR DRANK ANYTHING BEFORE THE INCIDENT AND SHE STATED HE PROBABLY DRANK SOMETHING, BUT HE DIDN'T EAT ANYTHING. CALLER STATED SHE DID NOT TREAT THE PATIENT BASED ON THE READING OF 107 RECEIVED ON THE PREMIER VOICE METER BECAUSE SHE DID NOT WANT TO GIVE HIM ANYTHING BECAUSE SHE WASN'T SURE WHAT HIS BLOOD GLUCOSE ACTUALLY WAS. THAT IS WHEN SHE CALLED THE PARAMEDICS. CALLER STATED THE PATIENT WAS TRANSFERRED TO GOOD (B)(6) HOSPITAL IN (B)(6) CALLER STATED INCIDENT HAPPENED EARLY THIS MOR

  Patient problems: Hypoglycemia

  MAUDE report 16712592 ↗
• MalfunctionNov 23, 2022Low Readings; Low Readings

  CUSTOMER COMPARES READINGS FROM THE DEXCOM AND THE RELION PREMIER CLASSIC METER EVERY TIME, SO WHEN THE READINGS WERE SO OFF, SHE KNEW THAT THE CLASSIC METER WAS NOT READING CORRECTLY BECAUSE SHE KNOWS HOW SHE FEELS WHEN SHE HAS LOW BLOOD GLUCOSE. SHE IS NO LONGER GOING TO COMPARE READINGS UNTIL SHE RECEIVES THE NEW METER. SHE STARTED HAVING THIS ISSUE SUNDAY MORNING, (B)(6) 2022. STRIPS WERE OPENED ON (B)(6) 2022. STORED IN THE CASE IN HER KITCHEN/DINING ROOM AND IT IS COOL AND DRY. IN ONE INSTANCE HER DEXCOM SHOWED 99 AND CLASSIC SHOWED LO. CALLER WENT AND HAD LUNCH AT 11:51 AM AND DEXCOM SHOWED 114 AND CLASSIC SHOWED 23. AT SUPPER, AT 3:49 PM, DEXCOM GAVE READING OF 300 AND CLASSIC SHOWED A READING OF 35. AT 9:11 PM, DEXCOM GAVE A READING OF 92 AND CLASSIC SHOWED 22. ON (B)(6) 2022, AT 5:14 AM, DEXCOM GAVE A READING OF 135 AND CLASSIC SHOWED 26. ALL THESE COMPARISONS ARE OUTSIDE OF ZONES A & B IN PARKES GRID. SHE IS USING DIFFERENT BLOOD SAMPLES FOR EACH TEST. REPLACED METER, STRIPS AND SENT RL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15850557 ↗
• MalfunctionSep 15, 2022Non Reproducible Results; Non Reproducible Results

  SERIAL NUMBER IS RUBBED OFF. CALLER STATED METER IS "ACTING UP" AND SHE'S SCARED THE METER IS NOT WORKING CORRECTLY. CALLER STATED FIRST THE METER READ LOW, LIKE "50SOMETHING", AND CALLER STATED SHE ALSO DOUBLECHECKS WHENEVER SHE HAS A LOW OR A HIGH READING. SO, SHE DID ANOTHER TEST AND RECEIVED A READING OF "HI" ON THE SCREEN. SHE WAITED 15 MINUTES AND TESTED AGAIN AND RECEIVED A READING OF 127. CALLER STATED THE READINGS OF "50SOMETHING", AND "HI" WERE WITHIN 10 MINUTES. CALLER STATED SHE USED A FRESH BLOOD SAMPLE FOR EACH READING. CALLER STATED SHE TRIES TO USE A NEW LANCET BEFORE EACH TEST. CALLER CLEANSES HANDS WITH SOAP AND WATER. CALLER THEN STATED THAT THIS METER IS USED ON HER DAUGHTER. DAUGHTER IS NOT ON OXYGEN THERAPY. TEST STRIPS WERE OPENED ABOUT A WEEK AGO. CALLER STATED THE TEST STRIP BOTTLE IS CLOSED IMMEDIATELY AFTER REMOVING A STRIP. TEST STRIPS AND METER ARE STORED TOGETHER IN THE POUCH, AND THEY ARE ALWAYS WITH THE CALLER. EXTRA TEST STRIPS ARE STORED IN A KITCHEN CABINET. CALLER STATED ALTHOUGH SHE CANNOT FIND HER CONTROL SOLUTION RIGHT NOW, THE LAST TIME SHE TESTED, IT TESTED WITHIN RANGE. CALLER STATED HER DAUGHTER IS 12 YEARS OLD. CALLER STATED THAT HER DAUG

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15424985 ↗
• MalfunctionAug 18, 2022Imprecise or Erratic Results; Imprecise or Erratic Results

  CUSTOMER CALLED BECAUSE THEIR RELION PREMIER VOICE METER WAS GIVING LO READINGS. CUSTOMER'S NORMAL BLOOD READINGS RANGE ABOUT 130-200. I EXPLAINED THE PROPER WAY TO PERFORM A BLOOD TEST, AND THIS DID NOT RESOLVE THE CUSTOMER'S ISSUE. FIRST BOTTLE OF 50 STRIPS WERE OPENED ON (B)(6) 2022 AND SECOND BOTTLE WAS OPENED DURING TODAY'S CALL, (B)(6) 2022. I EXPLAINED HOW TO REPLACE THE METER'S BATTERIES AND REQUESTED THAT THE CUSTOMER OPEN A NEW BOTTLE OF TEST STRIPS. I AGAIN EXPLAINED THE PROPER WAY TO COMPLETE A BLOOD TEST. THIS RESULTED IN A READING OF 230. WE TESTED A THIRD TIME AND RECEIVED A LO READING. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT, HOWEVER, DUE TO THE VARIANCE OF READINGS BEING GREATER THAN 20% AND THE READINGS FALLING IN ZONE C, I IDENTIFIED THIS COMPLAINT AS BEING REPORTABLE. CALLER CLEANSES HANDS APPROPRIATELY BEFORE TESTING AND USES A NEW LANCET EACH TIME. CALLER DOES NOT HAVE ANY TROUBLE GETTING A SAMPLE OF BLOOD. CALLER HAS NO RECENT CHANGES TO DIET, STRESS, MEDICATION, OR EXERCISE. CALLER STORES METER AND STRIPS TOGETHER IN POUCH. STRIPS ARE KEPT IN ORIGINAL VIAL. METER AND STRIPS HAVE NOT BEEN EXPOSED TO ANY EXTREME TEMPERATURES. METER WAS PURCHA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15247487 ↗
• MalfunctionJan 20, 2022Low Test Results; Low Test Results

  CUSTOMER STATED HER GLUCOSE MONITOR WAY IS WAY OFF FROM HER DOCTOR'S METER. HER METER READ 60, THEN HER DOCTOR'S READ 416. SHE SAID THIS HER SECOND METER SHE HAS RECEIVED, AND SHE'S HAD THE METER FOR ABOUT 3-4 MONTHS. SHE SAID SHE TOOK A READING ON HER METER EARLIER IN THE DAY BEFORE HER DOCTOR'S APPOINTMENT, AND IT READ HI. SHE TOOK INSULIN AND THEN SHE WENT TO HER DIALYSIS APPOINTMENT. WHEN SHE ARRIVED, THEY PERFORMED A BLOOD TEST ON THEIR METER. THEIR METER READ 416, THEN ABOUT 5 -10 MINUTES LATER THEY PERFORMED A BLOOD TEST USING HER METER AND IT READ 60. THIS IS AN 86% VARIANCE AND IN ZONE C IN PARKES GRID. SHE SAID THIS HAPPENED AROUND 11 AM THIS MORNING. SHE STATED THEY DID NOT PROVIDE ANY SORT OF TREATMENT AND THERE WASN'T ANY MEDICAL INTERVENTION AS THERE WAS NO ADVERSE EVENT. SHE'S HAD THE METER FOR ABOUT 3-4 MONTHS. THE METER APPEARS TO BE IN GOOD CONDITION. SHE'S NOT RECEIVING ANY OXYGEN THERAPY. SHE WASHES HER HANDS WITH SOAP AND WATER AND ALLOWS THEM TO DRY. SHE STORES BOTH METER AND TEST STRIPS INSIDE A MEDICINE BAG THAT SHE ALWAYS CARRIES WITH HER. CUSTOMER STATED SHE DID NOT LIKE THE VARIANCE IN RESULTS AND DOES NOT KNOW IF HER METER IS READING CORRECTLY AND SHE IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13312140 ↗
• InjuryMay 10, 2021High Readings; High Readings

  PATIENT HAS HAD THE PREMIER COMPACT FOR A YEAR. THE METER SERIAL NUMBER IS RUBBED OFF. PATIENT STATED THEY RECEIVED A READING OF 231. BECAUSE OF THIS HIGHER READING, THE PATIENT TREATED HIMSELF WITH INSULIN AND THEN WENT TOO LOW AND FAINTED AND BECAME UNCONSCIOUS. THE PARAMEDICS WERE CALLED. WHEN THE PARAMEDICS TOOK A FEW READINGS, THEIR METERS READ 20 WHEN TESTING THE PATIENT INDICATING THAT HIS BLOOD SUGAR WAS EXTREMELY LOW. PATIENT WAS TREATED BY THE PARAMEDICS WHO GAVE HIM GLUCOSE TO GET BACK TO A STABLE LEVEL. PATIENT WAS NOT TRANSFERRED TO A HOSPITAL AND FELT BETTER AFTER BEING TREATED BY THE PARAMEDICS. PATIENT IS CONCERNED THAT THE READING OF 231 WAS MOST LIKELY INACCURATE AND HIS BLOOD SUGAR WASN'T HIGH AT THE TIME OF THAT TEST, BECAUSE HE DIDN'T HAVE ANY SYMPTOMS AND FELT FINE, BUT THEN TREATED HIMSELF INAPPROPRIATELY BASED ON THE READING OF 231. PATIENT IS NOW UNSURE IF THE READINGS HE IS RECEIVING ARE ACCURATE. PATIENT HAD TESTED WITH CONTROL SOLUTION A MONTH AGO AND THE READING WAS IN RANGE, BUT THE CALLER NO LONGER HAS CONTROL SOLUTION TO TEST THE METER AGAIN AT THIS TIME. REPLACED METER, STRIPS, SENT CONTROL SOLUTION AND RETURN LABEL.

  Patient problems: Hypoglycemia

  MAUDE report 11798435 ↗
• InjuryMay 10, 2021Low Readings; Low Readings

  PATIENT STATED SHE DID NOTHING DIFFERENT ON DAY OF INCIDENT. PATIENT REPORTED RECEIVING A READING OF 121 IN THE MORNING AND FELT THE READING WAS NOT CORRECT AND HAD SYMPTOMS OF HYPERGLYCEMIA. PATIENT CLAIMED SHE DID NOT TREAT HERSELF BASED ON THE METER READING SINCE SHE WASN'T SURE WHAT TO DO. PATIENT CONTINUED TO FEEL UNWELL, SO SHE HAD HER NEIGHBORS CALL AN AMBULANCE AND WHEN THEY GOT TO HER, THEY CHECKED HER BLOOD GLUCOSE, AND IT WAS 351, INDICATING HER BLOOD GLUCOSE WAS HIGH. THE PARAMEDICS INFORMED HER THAT HER METER WAS NOT WORKING AND SET HER UP ON AN IV AND TOOK HER TO THE HOSPITAL WHERE SHE WAS TREATED AND RELEASED LATER IN THE DAY. REPLACED METER, STRIPS, SENT CS AND SENT RETURN LABEL.

  Patient problems: Hyperglycemia

  MAUDE report 11798259 ↗
• MalfunctionApr 30, 2021Low Readings; Low Readings

  CUSTOMER CALLED ORIGINALLY TO REQUEST CONTROL SOLUTION. SHE TRIED USING IT WITHOUT THE CONTROL SOLUTION AND SHE KEPT RECEIVING DIFFERENT ERROR MESSAGE. SHE TRIED TO GET SOLUTION THROUGH THE LOCAL PHARMACY AND WAS ADVISED TO CONTACT CUSTOMER SERVICE. WALKED CUSTOMER THROUGH A TEST AND SHE RECEIVED LO THEN ER4. CUSTOMER HAS HAD THE METER FOR TWO WEEKS. VERIFIED THAT SHE'S HAD THE METER AND STRIPS ABOUT ONE WEEK. WALKED CUSTOMER THROUGH A PROPER BLOOD TEST AND SHE ALLOWED THE STRIP TO ABSORB THE BLOOD SAMPLE BUT SHE RECEIVED LO AGAIN. VERIFIED SHE STORES THE METER AND STRIPS IN LOWER LEVEL ROOM LIKE LIVING ROOM OR BEDROOM. SHE HAS NOT BEEN MONITORING HER DIABETES AND DOES NOT KNOW WHAT HER NORMAL GLUCOSE READING TYPICALLY RANGE. WASHES HANDS WITH SOAP AND WATER AND ALLOW HANDS TO DRY THOROUGHLY. SHE DOES NOT HAVE TROUBLE RECEIVING A SAMPLE OF BLOOD. CUSTOMER IS NOT RECEIVING OXYGEN THERAPY. CUSTOMER DOES NOT HAVE SYMPTOMS TO MATCH LO. SEALS BOTTLE CAP TIGHTLY AND IMMEDIATELY AFTER REMOVING A TEST STRIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11751238 ↗
• InjuryApr 14, 2021High Readings; High Readings

  THE PATIENT HAS HAD THE RELION PREMIER COMPACT FOR A YEAR. THE METER SERIAL NUMBER IS RUBBED OFF. PATIENT STATED THAT THEY RECEIVED A READING OF 231MG/DL. BECAUSE OF THIS HIGHER READING, THE PATIENT TREATED HIMSELF WITH INSULIN AND THEN WENT TOO LOW AND FAINTED AND BECAME UNCONSCIOUS. THE PARAMEDICS WERE CALLED. WHEN THE PARAMEDICS TOOK A FEW READINGS, THEIR METER READ 20MG/DL WHEN TESTING THE PATIENT INDICATING THAT HIS BLOOD SUGAR WAS EXTREMELY LOW. PATIENT WAS TREATED BY THE PARAMEDICS WHO GAVE HIM GLUCOSE TO GET BACK TO A STABLE LEVEL. PATIENT WAS NOT TRANSFERRED TO HOSPITAL AND FELT BETTER AFTER BEING TREATED BY THE PARAMEDICS. PATIENT IS CONCERNED THAT THE READING OF 231MG/DL WAS MOST LIKELY INACCURATE AND HIS BLOOD SUGAR WAS NOT HIGH AT THE TIME OF THAT TEST, BECAUSE HE DID NOT HAVE ANY SYMPTOMS AND FELT FINE, BUT THEN TREATED HIMSELF INAPPROPRIATELY BASED ON THE READING OF 231MG/DL. PATIENT IS NOW UNSURE IF THE READING HE IS RECEIVING ARE ACCURATE. PATIENT HAD TESTED WITH CONTROL SOLUTION A MONTH AGO AND THE READING WAS IN RANGE, BUT THE CALLER NO LONGER HAS CONTROL SOLUTION TO TEST THE METER AGAIN AT THIS TIME.

  Patient problems: Hypoglycemia

  MAUDE report 11662628 ↗
• InjuryApr 1, 2021Low Readings; Low Readings

  PATIENT STATED SHE DID NOTHING DIFFERENCE ON DAY OF INCIDENT. PATIENT REPORTED RECEIVING A READING OF 121MG/DL IN THE MORNING AND FELT THE READING WAS NOT CORRECT AND HAD SYMPTOMS OF HYPERGLYCEMIA. PATIENT CLAIMED SHE DID NOT TREAT HERSELF BASED ON THE METER READING SINCE SHE WAS NOT SURE WHAT TO DO. PATIENT CONTINUED TO FEEL UNWELL, SO SHE HAD HER NEIGHBORS CALL AN AMBULANCE AND WHEN THEY GOT TO HER, THEY CHECKED HER BLOOD GLUCOSE, AND IT WAS 351MG/DL, INDICATING HER BLOOD GLUCOSE WAS HIGH. THE PARAMEDICS INFORMED HER THAT HER METER WAS NOT WORKING AND SET HER UP ON AN IV AND TOOK HER TO THE HOSPITAL WHERE SHE WAS TREATED AND RELEASED LATER IN THE DAY.

  Patient problems: Hyperglycemia

  MAUDE report 11600886 ↗
• InjuryMar 8, 2020High Test Results; High Test Results

  CUSTOMER IS CALLING BECAUSE SHE FEELS HER READINGS ARE HIGHER ON THE VOICE METER THAN HER ACCU-CHEK METER. VERIFIED SHE'S HAD THE VOICE METER SINCE (B)(6) 2019. OPENED TEST STRIPS ABOUT TWO WEEKS AGO. STORES SUPPLIES IN LINEN CLOSET. CUSTOMER IS NOT RECEIVING OXYGEN THERAPY. DOESN'T HAVE TROUBLE GETTING A SAMPLE OF BLOOD. CHANGES LANCETS EVERY TIME SHE TESTS. WASHES HANDS WITH SOAP AND WATER AND ALLOWS HANDS TO DRY THOROUGHLY. USES FINGERTIP AS A TESTING SITE. SEALS TEST STRIP BOTTLE TIGHTLY AND IMMEDIATELY AFTER REMOVING A TEST STRIP. CUSTOMER STATED LAST NIGHT SHE PERFORMED A BLOOD TEST ON ACCU-CHEK AND RECEIVED 112MG/DL AND THEN ON THE VOICE AND RECEIVED 167MG/DL. CUSTOMER DOESN'T HAVE CONTROL SOLUTION. EXPLAINED PURPOSE OF THE CS TEST. CUSTOMER WENT INTO EXPLAINING DETAILS ABOUT WHEN SHE FIRST NOTICED THAT THE VOICE METER WAS OFF DUE TO AN INCIDENT THAT OCCURRED LAST WEEK ON (B)(6) 2020. SHE STATED ON (B)(6) SHE TOOK A READING AT 1:30 AM BECAUSE SHE WOKE UP DUE TO SWEATING IN HER SLEEP. SHE RECEIVED 200MG/DL ON THE VOICE METER THEN USED HER MOM'S ACCU-CHEK AND THAT READ 22MG/DL. SHE TESTED ABOUT ONE MINUTE APART. SHE FELT HER SYMPTOMS DID NOT MATCH THE VOICE METER. SHE STATED T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9804044 ↗
• InjuryMar 4, 2020High Readings; High Readings

  CUSTOMER IS CALLING BECAUSE SHE FEELS HER READINGS ARE HIGHER ON THE VOICE METER THAN HER ACCU-CHEK METER. VERIFIED SHE'S HAD THE VOICE METER SINCE (B)(6) 2019. OPENED TEST STRIPS ABOUT TWO WEEKS AGO. STORES SUPPLIES IN LINEN CLOSET. CUSTOMER IS NOT RECEIVING OXYGEN THERAPY. DOESN'T HAVE TROUBLE GETTING A SAMPLE OF BLOOD. CHANGES LANCETS EVERY TIME SHE TESTS. WASHES HANDS WITH SOAP AND WATER AND ALLOWS HANDS TO DRY THOROUGHLY. USES FINGERTIP AS A TESTING SITE. SEALS TEST STRIP BOTTLE TIGHTLY AND IMMEDIATELY AFTER REMOVING A TEST STRIP. CUSTOMER STATED LAST NIGHT SHE PERFORMED A BLOOD TEST ON ACCU-CHEK AND RECEIVED 112 AND THEN ON THE VOICE AND RECEIVED 167. CUSTOMER DOESN'T HAVE CONTROL SOLUTION. EXPLAINED PURPOSE OF THE CS TEST. CUSTOMER WENT INTO EXPLAINING DETAILS ABOUT WHEN SHE FIRST NOTICED THAT THE VOICE METER WAS OFF DUE TO AN INCIDENT THAT OCCURRED LAST WEEK ON (B)(6) 2020. SHE STATED ON (B)(6) SHE TOOK A READING AT 1:30 AM BECAUSE SHE WOKE UP DUE TO SWEATING IN HER SLEEP. SHE RECEIVED 200 ON THE VOICE METER THEN USED HER MOM'S ACCU-CHEK AND THAT READ 22. SHE TESTED ABOUT ONE MINUTE APART. SHE FELT HER SYMPTOMS DID NOT MATCH THE VOICE METER. SHE STATED THE READING WAS WAY O

  Patient problems: Hypoglycemia

  MAUDE report 9786433 ↗
• MalfunctionOct 10, 2019Low Readings; Low Readings

  CALLER INDICATED METER WAS GIVING LOW RESULTS. METER IS ABOUT ONE MONTH OLD. HE RECEIVED THE CONTROL SOLUTION AND DID THE TEST AND SAID THE READING WAS LOW. RECEIVED 63MG/DL. THEY ALSO HAVE PRIME METER AND HE TESTED HIS BLOOD AND THE READING WAS 371MG/DL. THEN TESTED ON THE RELION PREMIER VOICE AND RECEIVED A READING OF 150MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9177124 ↗
• MalfunctionSep 29, 2019Low Readings; Low Readings

  CALLER INDICATED THE RELION PREMIER VOICE METER WAS GIVING VARIABLE READINGS. HE HAS ONLY HAD THE METER SINCE THE BEGINNING OF JUNE, AND HAS ONLY USED THREE TIMES. HE SAID THAT HE WAS GETTING INACCURATE READINGS. HE SAID THAT HE WAS GETTING DIFFERENT READINGS WHEN HE WAS DOING HIS TESTS AT HOME. CUSTOMER REFUSED TO DO ANY TROUBLESHOOTING. CUSTOMER WANTS A DIFFERENT METER. ADVISED TO TRY THE PREMIER BLU METER. SENT RETURN LABEL TO CUSTOMER TO SEND PRODUCTS BACK FOR TESTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9132504 ↗
• MalfunctionSep 20, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  CUSTOMER CALLED HE SAID THAT THE CAP ON THE STRIP BOTTLE BROKE WHEN HE TRIED TO OPEN IT AND DESICCANT SPILLED ALL OVER HIS BED. HE CALLED POISON CONTROL AND THEY SAID THAT IT WAS A DRYING AGENT. HE SAID THAT IT FLEW ALL OVER AND SOME MAY HAVE GOTTEN IN HIS FACE. THERE WAS NO DAMAGED TO THE BOTTLE PRIOR TO OPENING. HE HAS NOT REUSED BOTTLE. THE BEADS ARE VERY SMALL, SO HE IS CONCERNED ABOUT THE POSSIBILITY OF REMAINING DESICCANT AROUND HIS HOME. HIS MAJOR CONCERN WAS THAT THERE WAS NOT ANYTHING THAT COULD HAVE BEEN POISONOUS WITHIN THE DESICCANT. HE WAS NOT GIVEN A DIRECT ANSWER AS TO WHAT THE DESICCANT IS, AND THE PEOPLE HE SPOKE TO ACTED LIKE IT WAS NO BIG DEAL. HE FEELS THAT IT WAS NOT PROPERLY SEALED AND THAT IS WHAT LEAD TO THE DESICCANT FALLING OUT OF THE BOTTLE CAP. HE FEELS THAT THERE SHOULD BE SOMETHING IN THE INSERT OR LITERATURE ABOUT WHAT THE DESICCANT/CHEMICAL FOR ANY OTHER ISSUES THAT MAY HAPPEN IN THE FUTURE. THE DISTRIBUTOR EXPLAINED THAT THE BOTTLES WERE PURCHASED FROM A THIRD PARTY. REPLACED STRIP AND SENT RETURN LABEL. THE MSDS FOR THE DESICCANT WAS SENT TO THE CUSTOMER ON (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9096609 ↗