ReliOn® Prime Blood Glucose Monitoring System 701102Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00605388022929), received between Dec 7, 2016 and Jul 27, 2022 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2022Low Readings; Low Readings

  AROUND 3 AM, PATIENT (B)(6) STARTED TO FEEL SICK. SHE WOKE OUT OF HER SLEEP NOT FEELING WELL. SHE USED THE RELION PRIME METER TO PERFORM A BLOOD TEST AND RECEIVED A READING OF 165, THEN TOOK ANOTHER READING RIGHT AFTER AND RECEIVED 200. DURING THIS TIME, SHE WAS FEELING SICK AND VOMITING. SHE ALSO FELT NAUSEOUS. HER BOYFRIEND WAS WITH HER DURING THE TIME, AND HE TREATED HER WITH SUGAR FREE GATORADE BASED OFF THE READING OF 165 AND 200. THEY DID NOT GO TO THE HOSPITAL UNTIL AROUND 11 AM BECAUSE SHE WAS STILL FEELING SICK, NAUSEOUS, AND THROWING UP. HER BOYFRIEND DROVE HER TO THE ER AROUND 11 AM. AFTER THEY ARRIVED AT THE HOSPITAL, THEY CHECKED HER BLOOD SUGAR, AND THE READING WAS OVER 600. SHE WAS ALSO DEHYDRATED FROM VOMITING. THE ER TREATED HER WITH ABOUT TWO BAGS OF FLUID THROUGH AN IV. SHE WAS ADMITTED INTO THE HOSPITAL AND STAYED IN INTENSIVE CARE FOR A DAY AND A HALF. SHE WAS DISCHARGED FROM THE HOSPITAL YESTERDAY. I VERIFIED SHE'S HAD THE METER FOR ABOUT FOUR MONTHS. HER GLUCOSE TYPICALLY RANGES FROM 150-260. SHE TAKES LANTUS AND HUMALOG FAST ACTING FOR DIABETES. SHE'S A TYPE 1 DIABETIC. I VERIFIED SHE WASHES HER HANDS WITH SOAP, WATER AND USES ALCOHOL. SHE ALLOWS HER HANDS T

  Patient problems: Hyperglycemia

  MAUDE report 15111179 ↗
• InjurySep 11, 2020Incorrect Measurement; Incorrect Measurement

  CALLER'S NAME IS (B)(6). CALLER WANTED TO KNOW HOW TO TEST A METER. I INQUIRED WHAT THE CALLER MEANT, AND THEN EXPLAINED CONTROL SOLUTION TESTING. THE CALLER REPORTED THIS MORNING HIS BROTHER WAS TESTING HIS SUGAR AND HIS SUGAR WAS 30 POINTS OFF COMPARED TO THE PARAMEDIC'S METER. CALLER STATED THE METER WAS OLD. CALLER STATED PATIENT HAS HAD HIS METER FOR FIVE YEARS. I OFFERED REPLACEMENT METER AND EXPLAINED SHIPPING INFORMATION. I CALLED CALLER BACK TO GATHER INFORMATION FOR THE INCIDENT REPORT. INCIDENT HAPPENED THIS MORNING ((B)(6) 2020). WHEN ASKED ABOUT THE TEST STRIP INFORMATION, THE CALLER STATED HE WAS IN THE CAR RIGHT NOW GOING TO THE STORE, SO HE DID NOT HAVE THE TEST STRIP LOT AND EXPIRATION INFORMATION WITH HIM. CALLER STATED THE TEST STRIPS HAVE BEEN OPENED LESS THAN 90 DAYS. THE METER AND STRIPS ARE STORED TOGETHER IN THE LIVING ROOM CABINET. THE METER AND STRIPS HAVE NOT BEEN EXPOSED TO EXTREME TEMPERATURES. THE CALLER THEN STATED HE HAD TO GET GOING AND WHEN ASKED IF HE COULD CALL BACK LATER, HE STATED "NO, I'M VERY BUSY AND HAVE THINGS TO DO". WHEN ASKED WHY HE THINKS THE METER IS NOT WORKING PROPERLY, THE CALLER STATED, "IT WAS OFF COMPARED TO THE PARAMEDIC'S METE

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10521714 ↗
• InjuryAug 15, 2018High Readings; High Readings

  CALLER IS REPORTING HIGH READINGS. SHE PURCHASED THE METER AND TEST STRIPS THREE DAYS AGO. SHE STORES METER AND TEST STRIPS IN BEDROOM. SHE DOES NOT HAVE ANY CONTROL SOLUTION. SHE IS (B)(6) YEARS OLD. HER BIRTH DATE IS (B)(6). SHE WEIGHS AROUND (B)(6). CALLER IS A TYPE 2 DIABETIC. CALLER'S NORMAL READINGS ARE AROUND 300. CALLER SHOULD BE RECEIVING READINGS IN THE 200S ACCORDING TO HER DOCTOR. CALLER IS ON STEROIDS, BLOOD PRESSURE MEDICINES, HEARTBURN MEDICINES, CHOLESTEROL MEDICINES, PAINKILLERS, CHEMOTHERAPY MEDS, AND IS ALSO ON INSULIN. CALLER HAS RECENTLY CHANGED HER DIET. CALLER IS NOT ON OXYGEN THERAPY. CALLER CLEANSED FINGER WITH ALCOHOL. CALLER TESTS ON FINGERTIP. CALLER DID NOT USE A NEW LANCET. CALLER DID NOT HAVE A PROBLEM GETTING A BLOOD SAMPLE. CALLER LAYS THE METER DOWN WHEN TESTING. METER AND TEST STRIPS HAVE NOT BEEN EXPOSED TO EXTREME TEMPERATURES. CALLER RECEIVED BACK TO BACK READINGS OF 557 AND HI AND TOOK 16 UNITS OF INSULIN. CUSTOMER WAS ALARMED BECAUSE READINGS WERE SO HIGH. CUSTOMER CALLED THE PARAMEDICS. WHEN PARAMEDICS ARRIVED, THEY DID A TEST WITH THEIR METER AND RECEIVED 357. CUSTOMER DID ANOTHER TEST WITH HER METER AND IT STILL READ HI. CUSTOMER DID NOT H

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7786035 ↗
• InjuryMay 25, 2018Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  ARKRAY RECEIVED THIS COMPLAINT THROUGH THE FDA'S MEDWATCH PROGRAM AND THEN FOLLOWED UP WITH THE CUSTOMER TO GATHER MORE DETAILS. THE PATIENT RAN OUT OF HER NORMAL GLUCOMETER TEST STRIPS (FREESTYLE LITE), WHICH SHE HAS USED FOR MANY YEARS WITHOUT ISSUES, WHILE SHE WAS ON VACATION. PATIENT TRIED TO BY REPLACEMENT TEST STRIPS OVER-THE-COUNTER, BUT THEY WERE COST PROHIBITIVE FOR 100 STRIPS AT THE LOCAL PHARMACY. INSTEAD THEY PURCHASED A RELION PRIME METER AND TEST STRIPS. CALLER WANTS TO REPORT THIS GLUCOMETER BECAUSE THEY FEEL IT IS DANGEROUSLY UNRELIABLE. THEY ARE CERTAIN THE READINGS ARE INACCURATE, AS THE READINGS ROUTINELY READ EITHER LESS THAN 50 OR GREATER THAN 500. THE PATIENT OCCASIONALLY HAS SUCH EXTREME VALUES, BUT NOT WITH THIS FREQUENCY. THE CALLER IS EVEN MORE CONCERNED ABOUT THE IMPRECISION OF THE DEVICE, BECAUSE WHEN THEY CHECKED THE PATIENT'S BLOOD THREE TIMES IN ONE SITTING, THE NUMBERS FLUCTUATE TREMENDOUSLY. FOR EXAMPLE, ONE EVENING THE METER READ 467, 378, AND 515 WITHIN THE SPAN OF FIVE MINUTES. CLEARLY THE PATIENT'S BLOOD GLUCOSE LEVEL DID NOT CHANGE SO DRASTICALLY DURING THOSE FEW MINUTES. THESE KINDS OF VARIABLE RESULTS WERE RECEIVED MULTIPLE TIMES. BECAUSE OF

  Patient problems: Hypoglycemia

  MAUDE report 7545598 ↗
• MalfunctionNov 9, 2017Low Test Results; Device Displays Incorrect Message; Low Test Results; Device Displays Incorrect Message

  NO PHYSICAL DAMAGE TO THE METER. NO DEBRIS AROUND THE TEST STRIP PORT. PURCHASED METER BACK IN AUGUST. RECEIVED NEW ASSURE DOSE SOLUTION. CALLER IS GETTING E 13. WALKED CUSTOMER THROUGH A BLOOD TEST USING THE ASSURE DOSE SOLUTION, CUSTOMER GETS E 13 ERROR MESSAGE WHILE HOLDING STRIP VERTICAL. CUSTOMER NOT RECEIVING OXYGEN THERAPY. STORES IN OFFICE. CHANGES LANCETS SOMETIMES. WASHES HANDS WITH SOAP AND WATER. USES FINGERTIP AS A TESTING SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7014835 ↗
• InjuryAug 29, 2017Low Test Results; Low Test Results

  CALLER REPORTED THAT THE METER WAS GIVING INACCURATELY LOW READINGS WHICH CAUSED A SEIZURE AND HE ENDED UP IN THE HOSPITAL. CALLER REPORTED THAT HE'S TALKING WITH A LISP RIGHT NOW BECAUSE HE CHEWED HIS TONGUE. CALLER REPORTED THAT HE WAS OUT OF TOWN IN (B)(6) AND HE PURCHASED THE METER WHILE HE WAS THERE TO USE AND THEN PROCEEDED TO USE IT WHEN HE RETURNED TO (B)(6). HE TESTS 10-12 TIMES A DAY. CALLER STATED THE DEVICE HAD A SITUATION WHERE IT WAS NOT READING PROPERLY AND HE ENDED UP HAVING A SEIZURE, CHEWING HIS TONGUE UP, ENDED UP IN THE AMBULANCE AND HE ENDED UP HAVING A MEDICAL SITUATION WHERE HE ENDED UP HAVING THE PARAMEDICS COME. CALLER STATED THAT HE HAD THE SEIZURE ON THURSDAY, (B)(6) 2017. CALLER THEN WENT ON ABOUT SEIZURES SCREWING YOUR BRAIN UP AND IT KILLS BRAIN CELLS, AND WE OWE HIM BRAIN CELLS, PLAIN AND SIMPLE. CUSTOMER STATED THAT HE HAD LOW BLOOD SUGAR READINGS WHEN HE HAD THE SEIZURE AND HIS WIFE HAD TO PERFORM CPR TO REVIVE HIM, AND THAT IS WHEN THINGS TOOK AN UGLY TURN. HE THEN TALKED MORE ABOUT HOW IS WIFE NEEDED TO PERFORM CPR ON HIM AND HE HAS PHOTOS OF THE BRUISES TO PROVE IT. CALLER THEN PROVIDED THE FOLLOWING READINGS FROM HIS METER WHICH ALL WERE FROM TH

  Patient problems: Seizures

  MAUDE report 6827479 ↗
• MalfunctionJun 15, 2017Low Test Results; Low Test Results

  CALLER IS REPORTING LOW READINGS. CALLER WAS UNABLE TO GIVE SERIAL NUMBER COMPLETELY. CALLER REPORTED THAT SHE RECEIVED A READING OF 34, BUT WHEN SHE CALLED THE PARAMEDICS AND THEY DID A TEST, THEY RECEIVED A READING OF 124. CALLER REPORTED THAT HER NORMAL RANGE IS 105-124. CALLER STATED THAT THE PARAMEDICS WERE THERE TODAY, (B)(6) 2017. CALLER IS A TYPE 1 DIABETIC. CALLER DOES NOT TAKE INSULIN. CALLER STATED THAT SHE TAKES A BLOOD GLUCOSE TEST AND A BLOOD PRESSURE TEST EVERY MORNING. SHE IS ON NUMEROUS MEDICATIONS. CALLER STATED THAT SHE IS ON A NEW DIET. CALLER IS NOT ON OXYGEN THERAPY. CALLER CLEANSES HER HANDS WITH ALCOHOL BEFORE TESTING. CALLER TESTS ON HER FINGERTIP. CALLER DOES NOT USE A NEW LANCET EVERY TIME. THE PARAMEDICS TOLD HER SHE COULD USE THE SAME NEEDLE. CALLER IS SEEING HER DOCTOR ON THURSDAY AND IS GOING TO CHECK ABOUT LANCETS AS SHE DOES NOT EVEN KNOW IF SHE HAS OTHER LANCETS. CALLER VERIFIED THAT SHE HOLDS THE METER VERTICALLY AND BRINGS THE TEST STRIP TO THE DROP OF THE BLOOD. REP THEN ATTEMPTED TO VERIFY THE SERIAL NUMBER, AND THE CALLER REPORTED (B)(4), THE REP VERIFIED THOSE NUMBERS, AND THE CALLER CONFIRMED THE NUMBER. THE REP THEN TRIED TO VERIFY IF THERE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6643345 ↗
• MalfunctionJun 1, 2017Low Test Results; Low Test Results

  CALLER TESTING WITHIN HALF HOUR. CHANGES LANCETS EVERY TIME. STORES METER IN KITCHEN ON TABLE. RECEIVED 153 ON ULTIMA AND 88 ON PRIME AND THAT WAS WITHIN A FEW MINUTES APART. CALLER DOESN'T TRUST METER AT ALL. COMPARISON IS 42.484% VARIANCE AND THE WAS IN ZONE B. SENDING OUT RL TO CUSTOMER. SHE DOES NOT WANT PRIME METER AGAIN BUT IS WONDERING IF OUR COMPANY CAN SEND OUT ULTIMA. I INFORMED HER THAT WE DEAL WITH THE PRIME, CONFIRM AND MICRO METERS AND NOT THE ULTIMA, BUT I CAN REQUEST AND SEE, AND IF NOT HAVE SOMEONE CALL HER. PLEASE CALL HER IF UNABLE. SENT HER RL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6604954 ↗
• MalfunctionMay 11, 2017Low Test Results; Low Test Results

  CUSTOMER CALLED IN STATING THAT HER READINGS HAVE BEEN LOWER THAN NORMAL LATELY. SHE'S HAD THE METER FOR ABOUT A YEAR AND THE TEST STRIPS ARE PRIME AND WERE JUST RECENTLY OPENED ABOUT 2-3 WEEKS AGO. CUSTOMER IS A REGISTERED NURSE AND WAS TESTING ON HERSELF. SHE IS NOT A DIAGNOSED DIABETIC AND IS NOT TREATING WITH ANY MEDICATION BUT IS A PREDIABETIC AND WANTED BASELINE RESULTS. STRIPS WERE PURCHASED AT DIFFERENT TIMES. SHE NOTES THAT SHE REALIZED THE RESULTS WERE LOW BUT SHE FELT FINE SO DID NOT ACT IMMEDIATELY. SHE MENTIONED THIS TO HER MD AND THEY PROVIDED HER WITH A FREESTYLE. SHE NOTED THAT THE FREESTYLE WAS GIVING RESULTS THAT WERE NEARLY 40 POINTS HIGHER THAN HER PRIME. STRIPS ARE STORED IN A PANTRY; COOL AND DRY WITH NO HEAT OR HUMIDITY. STRIPS ARE REMOVED ONE AT A TIME AND BOTTLE IS RE-SEALED IMMEDIATELY. WE WENT OVER PROPER TESTING TECHINQUES AND SHE SEEMED TO BE FOLLOWING ALL THE CORRECT STEPS. I THEN OFFERED HER TO DO A TEST WITH CS BUT SHE DID NOT HAVE ANY SO I OFFERED TO GET SOME SENT OUT TO HER. SHE THEN STATED THAT SHE DOESN'T THINK IT'S THE STRIPS. SHE SAID SHE HAS BOUGHT A FEW DIFFERENT BOTTLES AND THEY CONTINUE TO ROUGHLY ALL READ LOWER THAN WHAT SHE SHOULD BE AT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6559678 ↗
• MalfunctionMar 6, 2017High Readings; High Readings

  CALLER REPORTING HIGH BLOOD GLUCOSE READINGS. CALLER DID NOT WANT TO TROUBLESHOOT AND WAS HIGHLY UPSET. STATED METER HAS BEEN READING 400 AND THE ACCU-CHEK IS READING 120-135. STATED THAT OUR METER IS CRAP AND THAT IT WILL KILL PEOPLE. GOT UPSET WITH ME WHEN VERIFYING ADDRESS AND SERIAL NUMBER AND DIDN'T WANT TO DO IT. CONTROLS NOT USED. SENT RETURN LABEL FOR CUSTOMER TO RETURN METER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6380197 ↗
• InjuryDec 7, 2016High Readings; High Readings

  CALLER REPORTING HIGH BLOOD GLUCOSE READING. SHE HAS NOT BEEN DIAGNOSED AS DIABETIC AND IS NOT BEING TREATED FOR DIABETES. SHE IS PREGNANT AND IS DEALING WITH SEVERE HYPOGLYCEMIA AND IS BEING MONITORED FOR IT. HER BLOOD SUGAR NORMALLY RUNS PRETTY LOW, SO SHE HAS ADJUSTED HER DIET TO CONSTANTLY BE EATING SUGAR TO KEEP BLOOD GLUCOSE LEVELS UP. HER BLOOD GLUCOSE NEVER USUALLY GOES ABOVE 140. CALLER RECEIVED A READING OF 464. CALLER WAS EXPERIENCING SYMPTOMS OF DIZZINESS AND LIGHTHEADEDNESS. SHE PANICKED AND CALLED 911. FIREMEN AND PARAMEDICS ARRIVED. PARAMEDICS DID BACK TO BACK READINGS USING THEIR METER AND THE RELION PRIME. THEY RECEIVED A READING OF 105 ON THE PARAMEDIC'S METER AND A READING OF 366 ON THE RELION PRIME. THIS IS A 71.3% VARIANCE AND IN ZONE C. PARAMEDICS DETERMINED THAT THE CALLER WAS INDEED LOW, BUT COULD NOT TREAT HER AS SHE'S NOT A DIABETIC. THEY MONITORED HER VITALS AND CHECKED FOR FETAL TONES ON THE BABY SINCE THE CALLER DEALS WITH HYPOGLYCEMIA. CALLER STATED THAT SHE DIDN'T EAT A STABLE MEAL THAT DAY AND FELT THIS COULD BE WHY SHE WASN'T FEELING WELL. SHE WAS SNACKING AND EATING SMALLER MEALS THROUGHOUT THE DAY. SHE TESTS EVERY TWO HOURS AND IS CONSTANTLY MONIT

  Patient problems: Hypoglycemia

  MAUDE report 6151776 ↗
• MalfunctionDec 7, 2016High Readings; High Readings

  CALLER INDICATED RELION PRIME METER WAS GIVING HIGH BLOOD READINGS. METER IS LESS THAN ONE WEEK OLD. BECAUSE OF HIGH READINGS SHE WENT INTO THE ER YESTERDAY. YESTERDAY AT 6:30 AM BEFORE SHE ATE, SHE TOOK A READING AND RECEIVED 478. SHE DID NOT TAKE INSULIN BUT CALLED HER DOCTOR TO REPORT THE HIGH READING AND WAS TOLD TO GO TO THE ER. SHE WAS TAKEN BY AMBULANCE. A READING WAS TAKEN IN THE AMBULANCE AND IT WAS 100 SOMETHING BUT SHE DOES NOT KNOW THE EXACT READING. INKTEL STATED THAT THE READING WAS 150. THE COMPARISON OF 478 AND 150 IS A 68.6% VARIANCE AND IS IN ZONE C. NO TREATMENT WAS GIVEN BECAUSE HER BLOOD GLUCOSE LEVEL WAS GOOD. CALLER DID STATE THAT SHE HAD ANOTHER MEDICAL ISSUE NOT RELATED TO HER BLOOD GLUCOSE VARIANCE THAT SHE WAS TREATED FOR AT THE HOSPITAL. NORMAL READINGS BEFORE EATING ARE 117. LANTUS AND METFORMIN ARE THE MEDICATIONS SHE TAKES. NO CHANGES TO DIET, EXERCISE, STRESS. SHE CLEANS THE TEST SITE (FINGER) WITH ALCOHOL AND CHANGES THE LANCET EVERY TIME. SHE HAS NO TROUBLE GETTING A BLOOD SAMPLE AND PERFORMS THE TEST CORRECTLY. CALLER IS INSULIN DEPENDENT. PLEASE EXPEDITE SHIPPING OF METER, STRIPS, CS AND SEND RL. CONTROLS NOT USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6151766 ↗