ReliOn® Prime Blood Glucose Monitoring System 701103Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00605388022936), received between Apr 20, 2017 and Nov 25, 2019 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “High Readings” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryMay 11, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  CALLER IS REPORTING BLOOD VARIABLE RESULTS. CALLER HAS OWNED METER FOR ONE MONTH. CALLER CALLED HAVING SOME PROBLEMS GETTING READINGS TO REGISTER. WENT THROUGH TECHNIQUE AND FOUND THAT METER IS PLACED ON THE TABLE WHEN APPLYING BLOOD AND CALLER PUTS HANDS AROUND IT TO APPLY TO THE SAMPLE. ATTEMPTED TO EXPLAIN HOW TO PROPERLY HOLD THE METER. AFTERWARD, CALLER STATED THAT THE METER'S BACK COVER WAS OFF WHERE THE BATTERY IS LOCATED AND SHE WAS HAVING TROUBLE GETTING METER TO WORK. LATER FOUND THAT METER WASN'T DAMAGED/DROPPED BUT CALLER HAS BEEN UNABLE TO GET COVER TO STAY ON. SHE LATER STATED THAT SHE ENDED UP IN THE HOSPITAL YESTERDAY AS A RESULT OF SOME EXTREME LOWS AND EXTREME HIGHS IN HER READINGS. CALLER STATED SHE IS GETTING VARIABLE READINGS; METER IS TESTING HIGH, BUT HER BLOOD SUGAR IS ACTUALLY LOW, OR HER METER IS READING LOW, BUT HER BLOOD SUGAR IS ACTUALLY HIGH. CALLER WAS VERY DIZZY AND SHE FELL. TREATMENT SPECIFICATIONS WERE NOT GIVEN BY THE CALLER. SHE JUST SAID THEY WANTED TO MONITOR HER LEVELS BUT DID NOT SPECIFY ON ANY MEDS GIVEN OR ANYTHING ELSE THAT WAS DONE TO BRING LEVELS BACK UP TO WHERE THEY SHOULD BE. SHE DIDN'T WISH TO STAY ON THE PHONE LONGER TO SPECIFY SO

  Patient problems: Hyperglycemia

  MAUDE report 6559676 ↗
• MalfunctionApr 20, 2017Missing Test Results; Missing Test Results

  CALLER INDICATED THE RELION PRIME METER WAS GIVING VARIABLE READINGS. CONTACTED CUSTOMER TO GATHER MORE INFORMATION. CUSTOMER STATED HE RECEIVED A READING OF HI AND LO IN ABOUT 10 MINUTES. HE WAS UPSET ABOUT NOT RECEIVING THE ORDER FOR CONTROL SOLUTION. HE WAS ALSO UPSET THAT IT DID NOT ARRIVE WITH THE OTHER REPLACEMENT METER THAT WAS SHIPPED BACK ON (B)(6) 2017. I SEARCHED THE HISTORY AND SAW WE RECEIVED THE CONTROL SOLUTION REQUEST THROUGH RELION.COM. I EXPLAINED THE PROCESS HOW IT WORKS WHEN HE CALLS IN TO REQUEST THE SOLUTION AND THAT THE REQUEST WERE SEPARATE. HE THEN PROCEEDED TO EXPLAIN HIS DISLIKING FOR THE METER. I APOLOGIZED AND EXPLAINED THAT BECAUSE OF THE READING HI AND LO WITHIN A 10 MINUTE TIME FRAME THAT I WOULD NEED TO COMPLETE AN INCIDENT REPORT. HE CONTINUED TO ASK ME WHY? WHAT FOR? I TRIED AGAIN TO EXPLAIN BECAUSE WE HAVE TO REPORT DETAILS TO THE FDA AND OUR REPLACEMENT PROCESS. HE REFUSED TO GIVE ME ANY INFORMATION OR ANSWER ANY OF MY QUESTIONS. HE STATED THAT THE QUESTIONS ARE TOO PERSONAL AND THAT IT'S HIS IMPORTANT INFORMATION. I WILL COMPLETE THE INCIDENT REPORT WITH THE DETAILS THAT I HAVE. THE CUSTOMER IS VERY UNCOOPERATIVE AND UNWILLING TO ANSWER THE QUE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6507268 ↗