GLUCOCARD® EXPRESSION Blood Glucose Monitoring System 570001Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00015482570101), received between Jan 31, 2018 and Mar 14, 2025 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (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, 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2025Low Readings; Low Readings

  CUSTOMER STATES SHE IS RECEIVING LOW READINGS ON HER TWO EXPRESSION METERS, AND SHE WENT TO THE ER AS A RESULT. CUSTOMER STATES HER CONTROL SOLUTION WAS OPENED IN (B)(6) 2024, BUT DID A TEST AND THOUGHT IT WAS OUT OF RANGE WITH A READING OF 105 AND THE RANGE WAS 90-122. ADVISED CUSTOMER THAT CONTROL SOLUTION IS GOOD FOR THREE MONTHS ONCE OPENED. THE CUSTOMER IS UNSURE HOW LONG SHE HAS HAD THE METERS. SHE STATES WE SENT HER ONE OF THEM AND THE OTHER SHE PURCHASED FROM HER LOCAL STORE. CUSTOMER STATES SHE USED BOTH METERS TODAY AND RECEIVED READINGS OF 62 AT 8:31AM WHICH CONCERNED HER AND PROMPTED HER TO GO TO THE HOSPITAL AROUND 8:49 AM. SHE USED TWO DIFFERENT SAMPLES ON TWO DIFFERENT HANDS USING A NEW LANCET. WHEN SHE WENT TO THE HOSPITAL, THEY TESTED HER AND RECEIVED A READING OF 105, AND AFTER EATING FOOD, THE READING WAS 189. THEY DISCHARGED HER AFTER MONITORING HER GLUCOSE AFTER EATING FOOD. WHEN SHE ARRIVED HOME, BOTH OF HER EXPRESSION METERS GAVE HER A RESULT OF 102, WHICH SHE STILL FEELS IS TOO LOW. CUSTOMER STATES SHE HAS HAD VERY CONTROLLED DIABETES FOR YEARS, BUT WITH THE LOW READINGS ON BOTH METERS AND THE WAY SHE WAS FEELING, SHE WENT TO THE HOSPITAL. CUSTOMER STORES ME

  Patient problems: Hypoglycemia

  MAUDE report 21603727 ↗
• InjuryMar 14, 2025Low Readings; Low Readings

  CUSTOMER STATES SHE IS RECEIVING LOW READINGS ON HER TWO EXPRESSION METERS, AND SHE WENT TO THE ER AS A RESULT. CUSTOMER STATES HER CONTROL SOLUTION WAS OPENED IN (B)(6) 2024, BUT DID A TEST AND THOUGHT IT WAS OUT OF RANGE WITH A READING OF 105 AND THE RANGE WAS 90-122. ADVISED CUSTOMER THAT CONTROL SOLUTION IS GOOD FOR THREE MONTHS ONCE OPENED. THE CUSTOMER IS UNSURE HOW LONG SHE HAS HAD THE METERS. SHE STATES WE SENT HER ONE OF THEM AND THE OTHER SHE PURCHASED FROM HER LOCAL STORE. CUSTOMER STATES SHE USED BOTH METERS TODAY AND RECEIVED READINGS OF 62 AT 8:31AM WHICH CONCERNED HER AND PROMPTED HER TO GO TO THE HOSPITAL AROUND 8:49 AM. SHE USED TWO DIFFERENT SAMPLES ON TWO DIFFERENT HANDS USING A NEW LANCET. WHEN SHE WENT TO THE HOSPITAL, THEY TESTED HER AND RECEIVED A READING OF 105, AND AFTER EATING FOOD, THE READING WAS 189. THEY DISCHARGED HER AFTER MONITORING HER GLUCOSE AFTER EATING FOOD. WHEN SHE ARRIVED HOME, BOTH OF HER EXPRESSION METERS GAVE HER A RESULT OF 102, WHICH SHE STILL FEELS IS TOO LOW. CUSTOMER STATES SHE HAS HAD VERY CONTROLLED DIABETES FOR YEARS, BUT WITH THE LOW READINGS ON BOTH METERS AND THE WAY SHE WAS FEELING, SHE WENT TO THE HOSPITAL. CUSTOMER STORES ME

  Patient problems: Hypoglycemia

  MAUDE report 21603646 ↗
• InjuryMar 11, 2025Low Readings; Low Readings

  CUSTOMER STATES SHE IS RECEIVING LOW READINGS ON HER TWO EXPRESSION METERS, AND SHE WENT TO THE ER AS A RESULT. CUSTOMER STATES HER CONTROL SOLUTION WAS OPENED IN (B)(6) 2024, BUT DID A TEST AND THOUGHT IT WAS OUT OF RANGE WITH A READING OF 105 AND THE RANGE WAS 90-122. ADVISED CUSTOMER THAT CONTROL SOLUTION IS GOOD FOR THREE MONTHS ONCE OPENED. THE CUSTOMER IS UNSURE HOW LONG SHE HAS HAD THE METERS. SHE STATES WE SENT HER ONE OF THEM AND THE OTHER SHE PURCHASED FROM HER LOCAL STORE. CUSTOMER STATES SHE USED BOTH METERS TODAY AND RECEIVED READINGS OF 62 AT 8:31 AM WHICH CONCERNED HER AND PROMPTED HER TO GO TO THE HOSPITAL AROUND 8:49 AM. SHE USED TWO DIFFERENT SAMPLES ON TWO DIFFERENT HANDS USING A NEW LANCET. WHEN SHE WENT TO THE HOSPITAL, THEY TESTED HER AND RECEIVED A READING OF 105, AND AFTER EATING FOOD, THE READING WAS 189. THEY DISCHARGED HER AFTER MONITORING HER GLUCOSE AFTER EATING FOOD. WHEN SHE ARRIVED HOME, BOTH OF HER EXPRESSION METERS GAVE HER A RESULT OF 102, WHICH SHE STILL FEELS IS TOO LOW. CUSTOMER STATES SHE HAS HAD VERY CONTROLLED DIABETES FOR YEARS, BUT WITH THE LOW READINGS ON BOTH METERS AND THE WAY SHE WAS FEELING, SHE WENT TO THE HOSPITAL. CUSTOMER STORES M

  Patient problems: Hypoglycemia

  MAUDE report 21572182 ↗
• InjuryMar 11, 2025Low Readings; Low Readings

  CUSTOMER STATES SHE IS RECEIVING LOW READINGS ON HER TWO EXPRESSION METERS, AND SHE WENT TO THE ER AS A RESULT. CUSTOMER STATES HER CONTROL SOLUTION WAS OPENED IN (B)(6) 2024, BUT DID A TEST AND THOUGHT IT WAS OUT OF RANGE WITH A READING OF 105 AND THE RANGE WAS 90-122. ADVISED CUSTOMER THAT CONTROL SOLUTION IS GOOD FOR THREE MONTHS ONCE OPENED. THE CUSTOMER IS UNSURE HOW LONG SHE HAS HAD THE METERS. SHE STATES WE SENT HER ONE OF THEM AND THE OTHER SHE PURCHASED FROM HER LOCAL STORE. CUSTOMER STATES SHE USED BOTH METERS TODAY AND RECEIVED READINGS OF 62 AT 8:31 AM WHICH CONCERNED HER AND PROMPTED HER TO GO TO THE HOSPITAL AROUND 8:49 AM. SHE USED TWO DIFFERENT SAMPLES ON TWO DIFFERENT HANDS USING A NEW LANCET. WHEN SHE WENT TO THE HOSPITAL, THEY TESTED HER AND RECEIVED A READING OF 105, AND AFTER EATING FOOD, THE READING WAS 189. THEY DISCHARGED HER AFTER MONITORING HER GLUCOSE AFTER EATING FOOD. WHEN SHE ARRIVED HOME, BOTH OF HER EXPRESSION METERS GAVE HER A RESULT OF 102, WHICH SHE STILL FEELS IS TOO LOW. CUSTOMER STATES SHE HAS HAD VERY CONTROLLED DIABETES FOR YEARS, BUT WITH THE LOW READINGS ON BOTH METERS AND THE WAY SHE WAS FEELING, SHE WENT TO THE HOSPITAL. CUSTOMER STORES M

  Patient problems: Hypoglycemia

  MAUDE report 21572137 ↗
• MalfunctionMar 15, 2024High Readings; High Readings

  COMPLAINED DEVICE SERIAL NUMBER: (B)(6) . CUSTOMER WAS UNABLE TO READ TEST STRIP INFORMATION. CUSTOMER CALLED STATING SHE NEEDS TO REPLACE HER METER DUE TO HER READINGS BEING HIGH AND ENDING UP IN THE EMERGENCY ROOM. THE PATIENT DESCRIBED WAKING UP AROUND 5 AM ON (B)(6) 2024, AND FEELING UNWELL AND EXPERIENCING INCREASED SWEATING AND WARMTH. SHE STATED FOR BREAKFAST SHE HAD TWO EGGS AND AN ORANGE AND DID NOT EAT ANYTHING FROM 12 - 8 PM. SHE GAVE HERSELF 80 UNITS OF LANTUS AT NOON. THROUGHOUT THE DAY, SHE MONITORED HER BLOOD SUGAR LEVELS, NOTICING THEY REMAINED ELEVATED. SHE STATED HER READINGS NORMALLY RANGE FROM 63 - 189. HER READING CAUSED CONCERN WHEN SHE STATED IT WAS READING AROUND 285 - 300 STILL LATE IN THE AFTERNOON. AT 8:35PM, SHE STATED SHE PERFORMED A BLOOD TEST WITH A READING OF 263, SHE WAITED FOR IT DECREASE BUT STATED IT DID NOT. THIS IS WHEN SHE ASKED HER SON TO TAKE HER TO THE ER FOR FURTHER EVALUATION. SHE STATED HER BLOOD GLUCOSE WAS RE-TESTED AND FOUND TO BE 140. MEDICAL STAFF OPTED FOR MONITORING RATHER THAN INTERVENTION, AND THEY STATED TO HER THIS IS A NORMAL READING, AND THE METER COULD POTENTIALLY DEFECTIVE AND ADVISED TO REPLACE METER. REPLACED METER, STRI

  Patient problems: Diaphoresis; Hypoglycemia

  MAUDE report 18910618 ↗
• InjuryMar 4, 2024High Readings; High Readings

  (B)(4). CUSTOMER WAS UNABLE TO READ TEST STRIP INFORMATION. CUSTOMER CALLED STATING SHE NEEDS TO REPLACE HER METER DUE TO HER READINGS BEING HIGH AND ENDING UP IN THE EMERGENCY ROOM. THE PATIENT DESCRIBED WAKING UP AROUND 5 AM ON (B)(6) 2024, AND FEELING UNWELL AND EXPERIENCING INCREASED SWEATING AND WARMTH. SHE STATED FOR BREAKFAST SHE HAD TWO EGGS AND AN ORANGE AND DID NOT EAT ANYTHING FROM 12-8 PM. SHE GAVE HERSELF 80 UNITS OF LANTUS AT NOON. THROUGHOUT THE DAY, SHE MONITORED HER BLOOD SUGAR LEVELS, NOTICING THEY REMAINED ELEVATED. SHE STATED HER READINGS NORMALLY RANGE FROM 63-189. HER READING CAUSED CONCERN WHEN SHE STATED IT WAS READING AROUND 285-300 STILL LATE IN THE AFTERNOON. AT 8:35 PM, SHE STATED SHE PERFORMED A BLOOD TEST WITH A READING OF 263, SHE WAITED FOR IT DECREASE BUT STATED IT DID NOT. THIS IS WHEN SHE ASKED HER SON TO TAKE HER TO THE ER FOR FURTHER EVALUATION. SHE STATED HER BLOOD GLUCOSE WAS RE-TESTED AND FOUND TO BE 140. MEDICAL STAFF OPTED FOR MONITORING RATHER THAN INTERVENTION, AND THEY STATED TO HER THIS IS A NORMAL READING, AND THE METER COULD POTENTIALLY DEFECTIVE AND ADVISED TO REPLACE METER. REPLACED METER, STRIPS, CONTROL SOLUTION AND SENT RETURN LA

  Patient problems: Diaphoresis; Hypoglycemia; Syncope/Fainting

  MAUDE report 18826142 ↗
• MalfunctionMar 4, 2020Incorrect Measurement; Incorrect Measurement

  CALLER'S PARENTS HAVE BEEN USING THIS METER FOR THREE YEARS AND IT HAS BEEN WORKING FINE. RECENTLY, THE METER HAS STARTED GIVING READINGS IN "MMOL/L" NOT "MG/DL". THERE IS NO WAY TO CHANGE THIS BACK. THE CALLER IS UNABLE TO SEND THE METER BACK, BECAUSE IT IS IN (B)(6). I EXPLAINED THE IMPORTANCE OF HAVING IT RETURNED, BUT THE CUSTOMER STATED THE SHIPPING OF THE METER WOULD COST MORE THAN THE METER ITSELF SO IT IS NOT COST EFFECTIVE TO HAVE IT SHIPPED FROM (B)(6) SO IT CAN BE RETURNED. CUSTOMER ALSO REQUESTED CONTROL SOLUTION. PLEASE REPLACE METER, SEND CONTROL SOLUTION, AND SEND RETURN LABEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9789916 ↗
• MalfunctionMar 4, 2020Incorrect Measurement; Incorrect Measurement

  (B)(6) OWNS AN EXPRESSION (OWNED THREE YEARS) AND INQUIRED: HOW DO WE CHANGE THE UNITS OF BLOOD GLUCOSE FROM MMOL/L BACK TO ORIGINAL MG/DL? HE HAS TAKEN THE BATTERIES OUT IN HOPES IT WOULD RESET TO FACTORY DEFAULT SETTINGS. HE WAS ABLE TO FIND A CONVERSION CHART BUT THAT WILL BECOME INCONVENIENT. METER HAD BEEN READING IN MG/DL AS OF FRIDAY, (B)(6) 2017, BUT THEN SOMETIME BEFORE SUNDAY, (B)(6) 2017, IT STARTED DISPLAYING RESULTS IN MMOL/L FORMAT. CUSTOMER REPORTED THAT THE METER HAS NOT BEEN DROPPED OR DAMAGED IN ANYWAY. I ASKED THE CUSTOMER ABOUT THE BATTERY PORT AND CUSTOMER STATED HE DID TRY CHANGING THE BATTERIES TO SEE IF THAT WOULD HELP. THERE WAS NO CORROSION OR BATTERY LEAKAGE EVIDENT IN THE BATTERY PORT AREA. CUSTOMER WAS AT WORK AND DID NOT HAVE THE METER WITH HIM TO GET THE SERIAL NUMBER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9789905 ↗
• MalfunctionMar 4, 2020Incorrect Measurement; Incorrect Measurement

  RESULTS ARE BEING DISPLAYED IN DECIMALS. CALLER IS CALLING IN ON BEHALF OF HER MOTHER. CUSTOMER HAS AN EXPRESSION METER, OWNED THREE YEARS. CUSTOMER INQUIRED HOW TO GET THE METER OUT OF DECIMAL MODE. READINGS FROM METER MEMORY: 4.6; 6.8 AND 11.1. (B)(4). CUSTOMER WAS INSTRUCTED ON THE RETURN LABEL PROCESS. I INFORMED THE CUSTOMER IT MAY TAKE 3-5 BUSINESS DAYS FOR DELIVERY VIA UPS. PLEASE REPLACE METER AND SEND RETURN LABEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9789889 ↗
• MalfunctionMar 4, 2020Incorrect Measurement; Incorrect Measurement

  METER IS READING IN MMOL/L INSTEAD OF MG/DL. WE DID A BLOOD TEST ON THE PHONE, AND I DID HEAR THE METER SAY MMOL/L. WILL REPLACE AND WILL SEND A RETURN LABEL. SHE THINKS SHE GOT THE METER FROM (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9789864 ↗
• MalfunctionMar 4, 2020Incorrect Measurement; Incorrect Measurement

  METER IS READING RESULTS IN MMOL. NO PHYSICAL DAMAGE TO THE METER. NO DEBRIS AROUND THE TEST STRIP PORT. WALKED CUSTOMER THROUGH A BLOOD TEST AND HIS READING WAS 8.3 MMOL. METER HAS NOT BEEN DROPPED. HE HAS OWNED THE METER FOR ABOUT 1-2 YEARS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9789834 ↗
• MalfunctionMar 4, 2020Incorrect Measurement; Incorrect Measurement

  (B)(6) PHARMACIST CALLING ON BEHALF OF CUSTOMER. CUSTOMER GAVE PERMISSION TO SPEAK WITH (B)(6). (B)(4). CALLER HAS OWNED METER FOR TWO YEARS. CUSTOMER WENT TO THE PHARMACY BECAUSE HER METER GIVING RESULTS IN MMOL/L. (B)(6) WANTED TO KNOW HOW TO GO ABOUT CHANGING IT BACK TO MG/DL. I EXPLAINED TO (B)(6) THAT THERE IS NO WAY TO GO ABOUT DOING SO AND WE WOULD BAVE TO REPLACE THE METER. PLEASE REPLACE METER AND SEND RETURN LABEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9789827 ↗
• MalfunctionMar 4, 2020Incorrect Measurement; Incorrect Measurement

  NO PHYSICAL DAMAGE TO THE METER. NO DEBRIS AROUND THE TEST STRIP PORT. CUSTOMER STATED THAT HER METER STARTED TO READ HER RESULTS AS MMOL. WALKED CUSTOMER THROUGH A PROPER BLOOD TEST AND SHE RECEIVED A READING OF 8.9 MMOL. THE METER READ THE RESULTS OUT LOUD AS MMOL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9789789 ↗
• InjuryMay 4, 2018Missing Test Results; Missing Test Results

  CALLER IS CALLING ON BEHALF OF HER MOTHER WHO RECEIVED LOW GLUCOSE LEVELS THIS MORNING. HER GLUCOSE HAS BEEN RUNNING HIGH LATELY AS SHE HAS BEEN SICK. NOT ON ANY STEROIDS THOUGH. THEY KEPT GIVING HER GLIPIZIDE TO DECREASE HER GLUCOSE LEVEL, AND THIS MORNING OUR METER READ 61, BUT CALLER FELT THAT IT WAS LOWER SO THEY CALLED AN EMS AND WHEN THEY ARRIVED ABOUT 15 MINUTES LATER AND DID A TEST, IT WAS 25 WITH THEIR METER. THIS IS 59.01% VARIANCE IN ZONE A, HOWEVER, IT WAS OUTSIDE THE 10-MINUTE TIME FRAME. THEY TREATED HER FOR LOW GLUCOSE WITH SUGAR SOLUTION. THEY GAVE HER SOMETHING TO DRINK AND ATE A PEANUT BUTTER SANDWICH. SHE REFUSED TO GO TO THE HOSPITAL. SHE HAS A HEART CONDITION AND HAS BEEN SICK FOR A LONG TIME. WE DID DO A CS TEST AND IT WAS 103 WHICH IS IN RANGE. THEY DID ANOTHER COMPARISON AND READING WAS 299 WITH THEIR METER, AND 213 WITH OURS. THIS IS A 28.76% VARIANCE IN ZONE A. THEY USED THE SAME BLOOD SAMPLE. CALLER HAS OWNED THE METER FOR ABOUT 2-3 MONTHS. STORES IN BEDROOM. CHANGES LANCET EVERY TIME. USES AN ALCOHOL WIPE AND SECOND DROP. PATIENT DOESN'T USUALLY HAVE DIFFICULTY WITH GETTING A SAMPLE. TESTS ON FINGERS ONLY. STRIPS HAVE BEEN OPEN ABOUT THREE WEEKS. KEEPS S

  Patient problems: Hypoglycemia

  MAUDE report 7486725 ↗
• MalfunctionJan 31, 2018Missing Test Results; Missing Test Results

  CUSTOMER STATED THAT SHE TESTED ON THE METER AND RECEIVED VARIANCES. SHE STATED THAT SHE RECEIVED THE FOLLOWING RESULTS: (B)(6). THE BACK TO BACK READINGS OF 20 AND 114 ARE AN 82.5% VARIANCE IN ZONE C. THERE WAS NO ADVERSE EVENT. PATIENT DID NOT TREAT HERSELF BASED ON READINGS AND RE-TESTED TO ENSURE SHE WAS RECEIVING THE CORRECT READINGS. CALLER STATED THAT PATIENT IS NOT RECEIVING OXYGEN THERAPY, USES FINGERTIP FOR TESTING, NO TROUBLE GETTING A SAMPLE OF BLOOD, CHANGES LANCETS EVERY TIME SHE TESTS. NORMAL GLUCOSE READINGS ARE 124-162. WASHES HANDS WITH SOAP AND WATER THEN ALLOWS TO DRY COMPLETELY, THEN CLEANSES FINGER WITH ALCOHOL AS WELL AND ALLOWS IT TO DRY. SHE STORES METER AND STRIPS IN HER BEDROOM. SEALS BOTTLE CAP TIGHTLY AND IMMEDIATELY AFTER REMOVING TEST STRIP. OPENED TEST STRIPS ABOUT ONE MONTH AGO. NO CONTROLS WERE USED AS CALLER DOES NOT HAVE CONTROL SOLUTION. REPLACED METER, TEST STRIPS, AND SENT RETURN LABEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7231283 ↗