ReliOn® Prime Blood Glucose Test Strips 700050 / 700100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00605388022943), received between Jun 11, 2019 and Apr 26, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2022Low Test Results; Low Test Results

  CUSTOMER REPORTED ISSUES OF LOW BLOOD READINGS. COMPLAINT WAS REVIEWED FOR INVESTIGATION AND REPORTABILITY ON (B)(6) 2022. COMPLAINT WAS MARKED FOR INVESTIGATION AND DETERMINED NOT REPORTABLE PER ARKRAY'S PER INTERNAL PROCEDURES. ON (B)(6) 2022, RETURNED STRIPS FAILED TESTING BY GENERATING LOW RESULTS OUT OF SPECIFICATION. THE STRIPS GAVE LOW READINGS, MAKING THIS COMPLAINT REPORTABLE TO THE MANUFACTURER AS A MALFUNCTION. (B)(6) 2022 MARKS THE AWARE DATE FOR MDR FILING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14208900 ↗
• MalfunctionSep 11, 2019Missing Test Results; Missing Test Results

  CALLER INDICATED THE RELION PRIME METER WAS GIVING VARIABLE READINGS. IT APPEARS TO BE WITH A NEW BOTTLE OF STRIPS. CALLER HAS THREE METERS, AND ALL ARE DOING THE SAME WITH THIS LOT. STRIPS ARE KEPT IN DINING ROOM. KEEPS STRIPS IN THE ORIGINAL BOTTLE. HE TRIED A DIFFERENT BOTTLE AND RECEIVED A 156 THEN TESTED THE BOTTLE HE CLAIMS GETTING LO AND RECEIVED 65. ALL FOUR BOTTLES OF STRIPS HAVE THE SAME LOT NUMBER. REPLACED SYSTEM AND SENT RETURN LABEL TO SEND PRODUCTS BACK FOR TESTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8988134 ↗
• InjuryJun 11, 2019Device Displays Incorrect Message; Device Displays Incorrect Message

  CALLER REPORTED THAT THE GLUCOSE METER IS NEW, AND SHE PURCHASED 200 TEST STRIPS. THE CALLER THEN STATED THAT SHE HAD BEEN IN THE HOSPITAL BECAUSE OF A DIABETIC COMA. THE REP ASKED IF THE HOSPITAL VISIT WAS IN RELATION TO THE METER AND THE CUSTOMER STATED, "WELL THE METER DIDN'T WORK, I KNOW THAT MUCH". THE REP THEN ASKED MORE ABOUT THE ADVERSE EVENT AND THE CALLER SIMPLY STATED SHE WENT INTO A COMA AND SHE DIDN'T EVEN KNOW SHE WAS A DIABETIC. THE CALLER WAS UNCOOPERATIVE IN ANSWERING ANY MORE QUESTIONS REGARDING THE EVENT. CALLER INDICATED THE HOSPITAL VISIT WAS IN RELATION TO THE METER "NOT WORKING," BUT WOULD NOT ELABORATE ON THE EVENT. ARKRAY ATTEMPTED TO GATHER INFORMATION AND REQUEST THE RETURN OF METER FROM THE CUSTOMER, BUT CUSTOMER REFUSED AND DISCARDED PRODUCT.

  Patient problems: Coma

  MAUDE report 8687818 ↗