ReliOn® Prime Blood Glucose Test Strips 700025Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00681131130332), received between Sep 25, 2018 and Mar 24, 2020 — classified as 5 injuries.

The most frequently reported specific device problem is “High Readings” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2020High Readings; High Readings

  PATIENT HAS OWNED THE METER FOR ONE WEEK. PATIENT STATED THAT HE WAS MISTREATING HIMSELF THROUGHOUT THE DAY BASED ON THE HIGH READINGS THE METER PROVIDED. ON (B)(6) 2020, PATIENT TOOK THREE READINGS THROUGHOUT THE DAY AND TREATED HIMSELF BASED ON THE READINGS AS FOLLOWS; 9:49 AM - 532 READING - 10 UNITS OF INSULIN; 1:38 PM - 331 READING - 7 UNITS OF INSULIN; 7:52 PM - 431 READING - 7 UNITS OF INSULIN. PATIENT THEN FELT SYMPTOMS BUT COULDN'T TELL IF HE WAS FEELING HYPERGLYCEMIC OR HYPOGLYCEMIC BECAUSE HE SOMETIMES FEELS THE SAME WAY FOR BOTH AND FELT THAT HIS BLOOD SUGAR WAS NOT UNDER CONTROL. PATIENT ALSO HAS EPILEPSY AND WAS EXPERIENCING "AURAS" DURING THIS TIME WHICH INDICATE A POSSIBLE SEIZURE MAY BE ONCOMING. BECAUSE HE FELT HIS BLOOD GLUCOSE WAS NOT UNDER CONTROL AND HE WAS WORRIED ABOUT HAVING A SEIZURE, HE WENT TO THE EMERGENCY ROOM. WHILE PATIENT WAS AT THE EMERGENCY ROOM, HE WAS TESTED WITH THE RELION PRIME METER AND RECEIVED A RESULT OF 402, AND WHEN THE HOSPITAL TESTED HIS BLOOD GLUCOSE WITH THEIR EQUIPMENT, THEY RECEIVED A READING OF 80, INDICATING THAT HE WAS HYPOGLYCEMIC. THE PATIENT WAS TREATED WITH A SALINE IV AND HIS BLOOD SUGAR WAS TESTED PERIODICALLY, AND HE WAS

  Patient problems: Hypoglycemia

  MAUDE report 9873378 ↗
• InjuryDec 6, 2019Low Test Results; Low Test Results

  CALLER HAS TWO PRIME METERS. (B)(4), WHICH IS SIX MONTHS OLD, AND (B)(4), WHICH WAS PURCHASED ON (B)(6) 2019 AND 25 CT. STRIP LOT 012119A WITH EXPIRATION 2020-08-15. CUSTOMER FIRST TESTED ON (B)(6) 2019 AND WAS RECEIVING LOW READINGS (54 AND 40). CUSTOMER NORMALLY TESTS BETWEEN 130-160. NEW METER (B)(4) WAS PURCHASED ON (B)(6) 2019 AND CALLER WAS RECEIVING LOW READINGS WITH THIS METER AS WELL (52 AND 57). CUSTOMER STATED SHE WAS EATING FOOD AND DRINKS THAT SHE NORMALLY WOULDN'T EAT OR DRINK TO GET SUGAR UP. CUSTOMER STARTED FEELING TIRED AND WENT TO ER ON (B)(6) 2019 AT ABOUT 3 AM. SHE COMPLETED A BLOOD TEST WITH HER NEW PRIME METER WHILE THERE AND RECEIVED 58. ER DID A READING WITH THEIR METER AND RECEIVED 168. BLOOD WORK SHOWED A READING OF 199 FOR GLUCOSE. NO MEDICATIONS GIVEN. CUSTOMER NOW WILL HAVE AN ER BILL. REPLACED METERS, STRIPS AND SENT RL.

  Patient problems: Hyperglycemia

  MAUDE report 9432441 ↗
• InjuryDec 6, 2019Low Test Results; Low Test Results

  CALLER HAS TWO PRIME METERS. (B)(4) WHICH IS SIX MONTHS OLD, AND (B)(4), WHICH WAS PURCHASED ON (B)(6) 2019 AND 25 CT. STRIP LOT 012119A WITH EXPIRATION 2020-08-15. CUSTOMER FIRST TESTED ON (B)(6) 2019 AND WAS RECEIVING LOW READINGS (54 AND 40). CUSTOMER NORMALLY TESTS BETWEEN 130-160. NEW METER (B)(4) WAS PURCHASED ON (B)(6) 2019 AND CALLER WAS RECEIVING LOW READINGS WITH THIS METER AS WELL (52 AND 57). CUSTOMER STATED SHE WAS EATING FOOD AND DRINKS THAT SHE NORMALLY WOULDN'T EAT OR DRINK TO GET SUGAR UP. CUSTOMER STARTED FEELING TIRED AND WENT TO ER ON (B)(6) 2019 AT ABOUT 3 AM. SHE COMPLETED A BLOOD TEST WITH HER NEW PRIME METER WHILE THERE AND RECEIVED 58. ER DID A READING WITH THEIR METER AND RECEIVED 168. BLOOD WORK SHOWED A READING OF 199 FOR GLUCOSE. NO MEDICATIONS GIVEN. CUSTOMER NOW WILL HAVE AN ER BILL. REPLACED METERS, STRIPS AND SENT RL.

  Patient problems: Hyperglycemia

  MAUDE report 9429461 ↗
• InjuryJun 25, 2019High Test Results; High Test Results

  THE METER IS FIVE MONTHS OLD AND THE CALLER IS RECEIVING HIGH READINGS ALONG WITH AN ERROR CODE THAT SHE IS NOT SURE ABOUT. NO DAMAGE OR LIQUID EXPOSURE OCCURRED WITH METER OR TEST STRIPS. CALLER RECEIVED A HIGH READING, OVER 300. ALTHOUGH CALLER WAS NOT HAVING ANY SYMPTOMS, SHE WAS CONCERNED ABOUT THE HIGH READING AND WENT TO THE ER ABOUT ONE HOUR AFTER TESTING. SHE DROVE HERSELF TO THE ER. THIS HAS NEVER HAPPENED WITH THIS METER AND IS THE ONLY METER PATIENT HAS EVER USED. CALLER STATES THE PHYSICIAN RECEIVED A LOW READING OF 65, THAT SHE WAS HYPOGLYCEMIC AND INFORMED PATIENT THAT THE METER WAS DEFECTIVE. THE HOSPITAL STAFF PROVIDED SUGARED ICE CHIPS UNTIL READINGS WERE WITHIN NORMAL RANGE. NO FURTHER TREATMENT WAS NEEDED. CALLER REPLACED BATTERIES IN MARCH. CALLER THEN STATED SHE RECEIVED AN ERROR CODE, BUT IT KEEPS SAYING IT WAS ALL EEE'S. CALLER IS NOT SURE WHAT ERROR CODE SHE RECEIVED AND COULD NOT GIVE A DEFINITIVE ANSWER ABOUT WHICH CODE IT WAS. INFORMED CALLER THAT ALL PRODUCTS INVOLVED IN THE INCIDENT (STRIPS AND METER) MUST BE RETURNED IMMEDIATELY. INFORMED CALLER THAT WE WILL REPLACE METER, TEST STRIPS, AND SEND CONTROL SOLUTION. INFORMED CALLER ON HOW TO PERFORM A CONT

  Patient problems: Hypoglycemia

  MAUDE report 8730688 ↗
• InjurySep 25, 2018High Readings; High Readings

  CALLER STATED PATIENT RECEIVED HIGH READINGS OF 432 - 481 - 414. CALLER STATED 433 READING WAS RECEIVED WHICH CAUSED PATIENT TO GO TO THE EMERGENCY ROOM. CALLER COMPARED TO ANOTHER METER AND OTHER METER READ 67 AND THIS METER READ 217. PATIENTS NAME IS (B)(6). PATIENT WENT TO THE EMERGENCY ROOM LAST NIGHT. PATIENTS' DATE OF BIRTH IS (B)(6). CALLER STATED PATIENT' AGE WAS (B)(6). PATIENTS WEIGHT IS (B)(6). PATIENT HAS TYPE 2 DIABETES. THE 120-140 IS RANGE OF TYPICAL BLOOD GLUCOSE READINGS. PATIENT TAKES 500MG OF METFORMIN TWICE A DAY. CALLER JUST STARTED TAKING METFORMIN LAST WEEK. CALLER IS NOT ON OXYGEN THERAPY. TESTS FROM FINGERTIP. PATIENT DOES NOT HAVE TROUBLE GETTING A BLOOD SAMPLE. METER AND TEST STRIPS WERE PURCHASED THE PREVIOUS DAY. STRIPS ARE STORED PROPERLY. METER AND STRIPS HAVE NOT BEEN EXPOSED TO ANY EXTREME TEMPERATURES. PATIENT HAS NO CONTROL SOLUTION. METER IS NEW, SO IT IS IN GOOD CONDITION. CALLER REPORTED SHE IS CALLING BECAUSE OF THE SPIKE OF NUMBERS BETWEEN READINGS. PATIENT HAD NO FOOD, BEVERAGES, OR MEDICATION BEFORE TESTS WERE PERFORMED. PATIENT DID HAVE SYMPTOMS OF BLURRED VISION. PATIENT DID NOT TREAT HIMSELF BASED ON METER READINGS, THEY JUST WENT TO THE

  Patient problems: Hyperglycemia

  MAUDE report 7905256 ↗