ReliOn Prime Blood Glucose Monitoring SystemRecalls & reported problems across all models
Wal-Mart Stores, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 2 models of ReliOn Prime Blood Glucose Monitoring System by Wal-Mart Stores, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Dec 7, 2016 and Jul 27, 2022 — classified as 9 injuries, 11 malfunctions.
The most frequently reported specific device problem is “High Readings” (7 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported ReliOn Prime Blood Glucose Monitoring System problems
Device problems
- High Readings7
- Low Test Results7
- Device Displays Incorrect Message2
- Incorrect Or Inadequate Test Results2
- Missing Test Results2
- Incorrect Measurement1
- Low Readings1
Patient problems
- No Known Impact Or Consequence To Patient12
- Hyperglycemia4
- Hypoglycemia4
- Seizures1
ReliOn Prime Blood Glucose Monitoring System models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ReliOn® Prime Blood Glucose Monitoring System 701102SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER12 reports
- ReliOn® Prime Blood Glucose Monitoring System 701103SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER8 reports
Recent ReliOn Prime Blood Glucose Monitoring System adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryNov 25, 2019Low Test Results; Low Test Results
REPORTER SAID THE METER WAS GIVING THE "WRONG" BLOOD SUGAR READINGS. REPORTER FOUND OUT THAT THE STRIPS SHE HAS AREN'T COMPATIBLE THE PRIME METER. CUSTOMER PURCHASED ONE TOUCH ULTRA TEST STRIPS ON APPROXIMATELY (B)(6) 2019 AND BEGAN USING THEM IN HIS PRIME METER. REPORTER THINKS IT WAS (B)(6) THAT PATIENT WENT TO THE HOSPITAL. WHEN HE GOT THERE HIS SUGAR WAS AT 800 AND HE WAS IN THE HOSPITAL FROM (B)(6). THEY RELEASED HIM BECAUSE HIS SUGAR LEVELS WENT DOWN. HE HADN'T BEEN FEELING WELL AND STAYED HOME MONDAY, TUESDAY, WEDNESDAY AND ON THURSDAY (B)(6) HE TOOK A READING AND RECEIVED 67. HE HAD A SCHEDULED DOCTOR'S APPOINTMENT THAT MORNING AT 8:40 AND RECEIVED A READING OF 500(SOMETHING) AND THEY SENT HIM BACK TO THE HOSPITAL. CALLER HAS TWO BOTTLES OF ONE TOUCH ULTRA TEST STRIPS LOT NUMBER 4549961, EXPIRATION 2020-12-31, 50CT. ARKRAY INFORMED THE REPORTER TO NOT USE ANY MORE OF THOSE TEST STRIPS WITH THE METER AND THEN INFORMED THE CUSTOMER OF THE CORRECT TEST STRIPS TO USE WITH THE RELION PRIME METER. THE REPORTER SAID THAT THE PATIENT WAS RECEIVING READINGS OF 197, 168, 154, 127. THE REPORTER THEN STATED IT WAS READING LOW. REPORTER ALSO STATED HE RECEIVED A READING OF 53 AND HE TH
Patient problems: Hyperglycemia
MAUDE report 9371772 ↗MalfunctionSep 4, 2018Missing Test Results; Missing Test Results
CALLER COULD NOT SEE THE LOT NUMBER ON THE STRIPS. CUSTOMER STATED THAT SHE IS GETTING INACCURATE READINGS. CALLER RECEIVED 398 WITH INKTEL AND CLAIMS THAT READING TO BE INACCURATE. ABOUT A HALF HOUR BEFORE SHE SAID SHE RECEIVED 38, AND ON THE OTHER HAND RECEIVED 512. CALLER THEN TOOK READING AGAIN AND IT WAS 259, THEN AGAIN IT WAS 249 WITHIN A MINUTE OR SO APART. CALLER DID NOT HAVE ANY FOOD, BEVERAGES, OR MEDICATION BEFORE THESE RESULTS. CALLER HAS NOT TREATED HERSELF BASED ON THESE RESULTS. CALLER CHANGES LANCETS FOR EVERY TEST. NO EXTREME TEMPERATURE CHANGES. STORES IN BEDROOM. METER IS ABOUT 14 DAYS OLD AT MOST. CALLER USES ALCOHOL WIPES AND TESTS ON THE SIDE OF HER FINGER. SHE DOES NOT HAVE TROUBLE GETTING A SAMPLE. NO CHANGES IN DIET OR EXERCISE. STRIPS ARE 50CT. CALLER IMMEDIATELY REPLACES CAP AFTER REMOVAL OF STRIP. STORES STRIPS IN BOTTLE THEY COME IN. WALKED THROUGH TEST AND FIRST TEST WAS 372 AND SECOND WAS 354. THIS IS A 4.8% VARIANCE. CALLER SAID SHE IS SLEEPY AND NOT FEELING WELL. SHE IS ON DIABETIC NEUROPATHY, HIGH BLOOD PRESSURE, AND ASPIRIN FOR MEDICATIONS. CALLER IS INSULIN DEPENDENT AND BASED ON OUR METER SHE IS UNSURE WHAT TO TAKE FOR INSULIN BECAUSE SHE SAYS O
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7842077 ↗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 ↗InjuryJan 31, 2018High Readings; High Readings
CALLER STATED ON (B)(6) 2017 HER PRIME METER GAVE HER A FALSE HIGH READING AND SHE WENT TO THE EMERGENCY ROOM BECAUSE OF IT. (B)(4). TEST STRIPS THAT WERE INVOLVED IN THE INCIDENT HAVE ALL BEEN USED, THE BOTTLE HAS BEEN THROWN AWAY, SO THE CUSTOMER DOES NOT KNOW THE LOT NUMBER OF THESE STRIPS. WHEN DOING HER BLOOD TESTS, SHE DOES USE PROPER TECHNIQUE EXCEPT FOR THE FACT SHE PRESSES THE TEST STRIP DIRECTLY TO HER FINGER. I INFORMED HER ABOUT THE TEST STRIPS ACTING LIKE A STRAW AND THE SUCTION MAY GET BLOCKED BY PRESSING THE TEST STRIP DIRECTLY TO HER FINGER. SHE WENT INTO THE HOSPITAL DUE TO HER READING BEING 419. HER NORMAL RANGE IS ANYWHERE FROM 80-120. SHE FELT DIZZY, NAUSEOUS, LETHARGIC, AND HER VISION WAS BLURRED. HER SYMPTOMS DID NOT MATCH THE READING. THESE SYMPTOMS ARE THE SYMPTOMS SHE FEELS WITH LOW READINGS, NOT HIGH ONES. SHE DID NOT TREAT HERSELF BASED ON THIS READING, BUT CALLED THE HOSPITAL AND WAS ADVISED TO COME IN IMMEDIATELY. AT THE HOSPITAL, THEY POKED HER FINGER AND RECEIVED A READING OF 130, WHEREAS THE BLOOD GLUCOSE READING FROM THE BLOOD DRAW FOR THE LAB WAS 120. THE DOCTOR TOLD BETH TO CONTACT US AS THERE MAY HAVE BEEN A MALFUNCTION WITH THE PRODUCTS. SHE WAS
Patient problems: Hypoglycemia
MAUDE report 7231296 ↗MalfunctionNov 15, 2017Low Test Results; Device Displays Incorrect Message; Low Test Results; Device Displays Incorrect Message
CALLER STATED METER IS GIVING INACCURATE READINGS. CALLER RECEIVED A READING OF 72 AND STATED THAT IS TOO LOW AND SHE OFTEN GETS LOWER READINGS THAN THAT. CALLER DIDN'T WANT CS, JUST WANTED REFUND. CALLER PURCHASED METER ON AUGUST 25, 2017. CALLER PURCHASED STRIPS IN AUGUST AS WELL. SHE WENT TO DOCTOR ON (B)(6) AND RECEIVED 267, AND RECEIVED 183 AT LAB. CALLER DOESN'T TRUST THIS METER AND IS GOING TO BUY ANOTHER METER AND STRIPS BECAUSE SHE WILL BE IN THE HOSPITAL FOR TWO MONTHS AND NEEDS IT NOW WITH HER REFUND. SHE DOES WANT CS, BUT WANTS TO SEND THIS METER AND STRIPS BACK. SENT CUSTOMER A RETURN LABEL TO SEND PRODUCTS BACK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7032880 ↗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 27, 2017High Readings; High Readings
CALLER IS REPORTING HIGH BLOOD READINGS. DATE OF THE INCIDENT WAS (B)(6) 2017. SHE TRIED CALLING TWO TIMES YESTERDAY (5/23/2017) BUT SHE WAS ON HOLD FOR 30 MINUTES EACH TIME. CALLER RECEIVED A READING OF 392 AND BECAME ALARMED, SO SHE CALLED HER DOCTOR, AND HER DOCTOR TOLD HER TO CALL 911 AND GET TO THE HOSPITAL. CALLER WAS HAVING SYMPTOMS OF DIZZINESS, SHAKY, SHE HAD VERY BAD HEADACHE, AND HER STOMACH WAS QUEASY. SHE DID NOT FEEL THESE SYMPTOMS MATCHED THE READING SHE RECEIVED. WHEN THE PARAMEDICS CAME, THE RECEIVED A READING OF 90. SHE DID NOT TAKE ANY MEDICATION AT THE TIME OF THE INCIDENT. EARLIER IN THE DAY SHE HAD EATEN AND TAKEN HER NORMAL DOSE OF 18 UNITS OF INSULIN. WHEN SHE GOT TO THE HOSPITAL, HER BLOOD GLUCOSE WAS 90. AT THE HOSPITAL, SHE WAS DIAGNOSED WITH A BLADDER AND KIDNEY INFECTION. THERE HAVE NOT BEEN ANY CHANGES IN HER DIET, EXERCISE, MEDICATIONS, OR STRESS. SHE IS NOT UNDERGOING OXYGEN THERAPY. SHE WASHES AND DRIES HER HANDS WITH SOAP AND WATER. SHE POKES ON THE FINGERTIP AND USES A NEW LANCET EACH TIME. SHE USUALLY DOESN'T HAVE PROBLEMS GETTING A BLOOD SAMPLE, ONLY WHEN HER READINGS ARE LOW SHE HAS A HARDER TIME. SHE HOLDS THE METER AND TEST STRIP STRAIGHT OUT
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6670258 ↗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 24, 2017High Readings; High Readings
CALLER STATED THAT SHE IS GETTING HIGH READINGS. CALLER'S NORMAL READING RANGE IS 130-140. CALLER STATED THAT SHE HAD TO VISIT THE HOSPITAL BECAUSE OF THE READINGS FROM THIS METER. YESTERDAY, (B)(6) 2017, SHE RECEIVED A READING OF 472 AND HAD SYMPTOMS AND CALLED HER DOCTOR WHO ADVISED HER TO CALL 911. THE AMBULANCE CAME FIVE MINUTES LATER AND THEY RECEIVED A READING OF 132 ON THEIR METER. WHEN SHE GOT TO THE HOSPITAL, THEY RECEIVED A READING OF 89. WHEN ASKED IF SHE WAS TREATED WITH ANYTHING AT THE HOSPITAL, THE CALLER STATED THAT THEY DID NO TREATMENT AT ALL. CALLER ALSO NOTED THAT SHE WAS DIAGNOSED WITH VERTIGO WHEN SHE WENT TO THE HOSPITAL. WHEN ASKED IF THE SYMPTOMS SHE FELT MATCHED LOW OR HIGH BLOOD SUGAR, CALLER STATED THAT GENERALLY SHE FEELS THE SAME WAY WHETHER SHE'S HIGH OR LOW. CALLER WASHES AND DRIES HANDS BEFORE TESTING, AND ALSO USES ALCOHOL. SHE IS TESTING FROM THE FINGERTIP AND USES A STERILE LANCET BEFORE TESTING. CALLER SOMETIMES HAS ISSUES GETTING A BLOOD SAMPLE. TESTING TECHNIQUE IS CORRECT. CUSTOMER REPORTED THAT SHE DID A CONTROL SOLUTION TEST ON (B)(6) 2017, AND RECEIVED A RESULT OF 106, WHICH WAS OUT OF RANGE AS THE RANGE ON HER STRIP BOTTLE IS 83-103. SINCE
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6587042 ↗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 ↗
Other Wal-Mart Stores, Inc. products
All Wal-Mart Stores, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page