GLUCOCARD® EXPRESSION Blood Glucose Test Strips 570050Recalls & reported problems
Arkray USA, Inc. · Blood Glucose Test Strips · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00015482570057), received between Feb 7, 2020 and Mar 12, 2025 — classified as 14 injuries, 2 malfunctions.
The most frequently reported specific device problem is “High Readings” (11 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.
Reports received per month
Most reported problems
Device problems
- High Readings11
- High Test Results3
- Missing Test Results2
Patient problems
- Hypoglycemia14
- Malaise1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2025High Readings; High Readings
CUSTOMER REPORTED ISSUES OF HIGH CONTROL SOLUTION READINGS. COMPLAINT WAS REVIEWED FOR INVESTIGATION AND REPORTABILITY ON DECEMBER 6, 2024. COMPLAINT WAS MARKED FOR INVESTIGATION AND DETERMINED NOT REPORTABLE PER ARKRAY'S PER INTERNAL PROCEDURES.ON JANUARY 28, 2025, THE RETURNED STRIPS FAILED TESTING BY GENERATING HIGH RESULTS OUT OF SPECIFICATION. THE STRIPS GAVE HIGH READINGS, MAKING THIS COMPLAINT REPORTABLE TO THE MANUFACTURER AS A MALFUNCTION. JANUARY 28, 2025 MARKS THE AWARE DATE OF MDR FILING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21590656 ↗InjuryJun 19, 2023High Readings; High Readings
FRIEND (B)(6) IS CALLING IN FOR CUSTOMER. (B)(6). CUSTOMER HAS HAD THE METER FOR APPROXIMATELY TWO YEARS SHE THINKS. LOT B4S2201010 - 20230-10-11 - 50CT. CUSTOMER IS RECEIVING HIGHER READINGS. YESTERDAY THE CUSTOMER CALLED HER FRIEND BECAUSE SHE WAS NOT FEELING WELL. FRIEND (B)(6) METER READ 64 AND ROSA'S METER READ 280 IN A COMPARISON TEST. (B)(6) HAS NOVA MAX PLUS METER.THE FOLLOWING IS FROM THE HISTORY OF THE TWO METERS. PLEASE NOTE THE DATE IS INCORRECT ON ROSA'S METER AND THE CALLER IS UNSURE IF THE TIME IS SET CORRECTLY: CUSTOMER'S METER - (B)(6) - 5:36 - 280 WAS THE READING RECEIVED AND CUSTOMER CALLED HER FRIEND TO LET HER KNOW SHE WAS NOT FEELING WELL. CALLER'S METER - (B)(6) - 64 WAS THE READING RECEIVED AFTER SHE GOT TO HER HOURSE AROUND THE SAME TIME. CALLER GAVE CUSTOMER JUICE AT THIS TIME. CALLER'S METER - (B)(6) - 1:22PM - 143. THE FOLLOWING READINGS ARE THE READINGS RECEIVED ON THE CUSTOMER'S METER THAT CUSTOMER IS CLAIMING ARE TOO HIGH BEFORE THE INSTANCE OF THE COMPARISON READINGS ABOVE: (B)(6) - 18:05 - 336, (B)(6) - 18:08 - 208, (B)(6) - 18:08 - 288, (B)(6) - 18:09 - 274. (B)(6) STATES THAT THE READINGS FROM (B)(6) WERE NOT DONE WITH THE SAME BLOOD SAMPLE, BUT M
Patient problems: Hypoglycemia
MAUDE report 17159984 ↗InjuryMay 22, 2023High Readings; High Readings
FRIEND RAQUEL IS CALLING IN FOR CUSTOMER. RJ038296. CUSTOMER HAS HAD THE METER FOR APPROXIMATELY TWO YEARS SHE THINKS. LOT B4S2201010 - 2023-10-11 - 50CT. CUSTOMER IS RECEIVING HIGHER READINGS. YESTERDAY THE CUSTOMER CALLED HER FRIEND BECAUSE SHE WAS NOT FEELING WELL. FRIEND RAQUEL'S METER READ 64 AND ROSA'S METER READ 280 IN A COMPARISON TEST. RAQUEL HAS NOVA MAX PLUS METER. THE FOLLOWING IS FROM THE HISTORY OF THE TWO METERS. PLEASE NOTE THE DATE IS INCORRECT ON ROSA'S METER AND THE CALLER IS UNSURE IF THE TIME IS SET CORRECTLY: CUSTOMER'S METER - 8/28 - 5:36 - 280 WAS THE READING RECEIVED AND CUSTOMER CALLED HER FRIEND TO LET HER KNOW SHE WAS NOT FEELING WELL. CALLER'S METER - 4/26 - 64 WAS THE READING RECEIVED AFTER SHE GOT TO HER HOUSE AROUND THE SAME TIME. CALLER GAVE CUSTOMER JUICE AT THIS TIME. CALLER'S METER - 4/26 - 1:22 PM - 143. THE FOLLOWING READINGS ARE THE READINGS RECEIVED ON THE CUSTOMER'S METER THAT CUSTOMER IS CLAIMING ARE TOO HIGH BEFORE THE INSTANCE OF THE COMPARISON READINGS ABOVE: 8/24 - 18:05 - 336, 8/24 - 18:08 - 208, 8/24 - 18:08 - 288, 8/24 - 18:09 - 274. RAQUEL STATES THAT THE READINGS FROM 8/24 WERE NOT DONE WITH THE SAME BLOOD SAMPLE, BUT MAY HAVE BEEN
Patient problems: Hypoglycemia; Malaise
MAUDE report 16974293 ↗InjuryDec 13, 2022High Readings; High Readings
THE CALLER INDICATED THE GLUCOCARD EXPRESSION METER WAS READING HIGH. THE CALLER PERFORMED A CONTROL SOLUTION TEST WITH A RESULT OF 117, WITH A RANGE OF 97-117. THEN THE CALLER FOUND THIS CONTROL SOLUTION TO BE FOR A RELION PREMIER METER (CSTN04CN), WHICH IS THE INCORRECT CONTROL SOLUTION FOR GLUCOCARD EXPRESSION METER. THE CALLER PERFORMED BACK-TO-BACK BLOOD TESTS WITH RESULTS OF 108 AND 110. IMPORTER EXPLAINED 20% VARIANCE. THE CUSTOMER STATED THAT LAST NIGHT AT 3:30 AM THEY WERE FEELING BAD. CUSTOMER STATED THEY WERE FEELING DISORIENTED AND TESTED THEIR BLOOD SUGAR WITH A RESULT OF 75. THE CUSTOMER CALLED THE PARAMEDICS WHO ARRIVED AND TESTED THEIR BLOOD GIVING THEM A READING OF 35. THE PARAMEDICS ADVISED THAT THEY EAT FOOD TO INCREASE THEIR BLOOD SUGAR, SO THEY ATE A PEANUT BUTTER SANDWICH AND DRANK A SODA. THE CUSTOMER TOLD IMPORTER THAT THE REASON THEY CALLED THE PARAMEDICS WAS DIRECTLY DUE TO THE READINGS OF THE METER. IMPORTER EXPLAINED THAT THEY WOULD SEND A REPLACEMENT METER AND TEST STRIPS AND THEY WOULD ARRIVE IN 3-5 BUSINESS DAYS WITH A RETURN LABEL TO SEND BACK THE COMPLAINT PRODUCTS.
Patient problems: Hypoglycemia
MAUDE report 15967562 ↗InjuryDec 6, 2022High Test Results; High Test Results
THE CALLER INDICATED THE GLUCOCARD EXPRESSION METER WAS READING HIGH. WE PERFORMED A CONTROL SOLUTION TEST WITH A RESULT OF 117, WITH A RANGE OF 97-117. FOUND THIS CONTROL SOLUTION TO BE FOR A RELION PREMIER METER (CSTN04CN), WHICH IS THE INCORRECT CONTROL SOLUTION FOR THIS PRODUCT. WE PERFORMED BACK-TO-BACK BLOOD TESTS WITH RESULTS OF 108 AND 110. I EXPLAINED 20% VARIANCE. THE CUSTOMER STATED THAT LAST NIGHT AT 3:30 AM THEY WERE FEELING BAD. CUSTOMER STATED THEY WERE FEELING DISORIENTED AND TESTED THEIR BLOOD SUGAR WITH A RESULT OF 75. THE CUSTOMER CALLED THE PARAMEDICS WHO ARRIVED AND TESTED THEIR BLOOD GIVING THEM A READING OF 35. THE PARAMEDICS ADVISED THAT THEY EAT FOOD TO INCREASE THEIR BLOOD SUGAR, SO THEY ATE A PEANUT BUTTER SANDWICH AND DRANK A SODA. THE CUSTOMER TOLD ME THAT THE REASON THEY CALLED THE PARAMEDICS WAS DIRECTLY DUE TO THE READINGS OF THE METER. I EXPLAINED THAT WE WOULD SEND A REPLACEMENT METER AND TEST STRIPS AND THEY WOULD ARRIVE IN 3-5 BUSINESS DAYS WITH A RETURN LABEL TO SEND BACK THE COMPLAINT PRODUCTS. REPLACED METER, STRIPS AND SENT RETURN LABEL.
Patient problems: Hypoglycemia
MAUDE report 15923908 ↗InjuryMay 10, 2021Missing Test Results; Missing Test Results
PATIENT SAID SHE TOOK A READING AND RECEIVED 120, AND THEN TOOK ANOTHER READING AND RECEIVED 300. THESE READINGS WERE WITHIN 10 MINUTES. THIS OCCURRED SATURDAY, (B)(6) 2021 IN THE EVENING. SHE SAID SHE DIDN'T HAVE ANY SYMPTOMS. SHE THOUGHT SHE WAS OKAY. SHE DIDN'T EAT ANYTHING TO HELP LOWER HER BLOOD SUGAR. SHE DIDN'T TAKE ANY INSULIN. SHE DIDN'T HAVE ANY FOOD, BEVERAGES, OR MEDICINE TWO HOURS PRIOR. LATER, SHE WENT TO SLEEP LATER FOR A WHILE. HER HUSBAND TRIED TO WAKE HER UP, BUT SHE WASN'T RESPONDING TO HIM. HER HUSBAND CALLED THE PARAMEDICS AROUND 3 OR 4 AM. SHE SAID THE PARAMEDICS USED THEIR METER TO TEST HER GLUCOSE AND THEY RECEIVED 42. THEY GAVE HER SOMETHING TO HELP INCREASE HER GLUCOSE. SHE STARTED TO COME BACK TO HER NORMAL SELF AFTER THEY TREATED HER. SHE STORES METER IN HER BEDROOM. CUSTOMER IS NOT RECEIVING OXYGEN THERAPY. SHE DOESN'T HAVE TROUBLE GETTING A SAMPLE OF BLOOD AND SEALS STRIP BOTTLE TIGHTLY AND IMMEDIATELY AFTER OPENING. USES FINGERTIP AS A TESTING SITE. USES ALCOHOL TO CLEANSE TESTING SITE AND ALLOWS HANDS TO DRY THOROUGHLY. OPENED TEST STRIP BOTTLE LAST MONTH. VERIFIED THERE'S NO CHANGES IN DIET, EXERCISE OR STRESS LEVELS. VERIFIED SHE CHANGE THE LANCET
Patient problems: Hypoglycemia
MAUDE report 11798631 ↗InjuryApr 9, 2021High Readings; High Readings
PATIENT SAID SHE TOOK A READING AND RECEIVED 120, AND THEN TOOK ANOTHER READING AND RECEIVED 300. THESE READINGS WERE WITHIN 10 MINUTES. THIS OCCURRED SATURDAY, (B)(6) 2021 IN THE EVENING. SHE SAID SHE DIDN'T HAVE ANY SYMPTOMS. SHE THOUGHT SHE WAS OKAY. SHE DIDN'T EAT ANYTHING TO HELP LOWER HER BLOOD SUGAR. SHE DIDN'T TAKE ANY INSULIN. SHE DIDN'T HAVE ANY FOOD, BEVERAGES, OR MEDICINE TWO HOURS PRIOR. LATER, SHE WENT TO SLEEP LATER FOR A WHILE. HER HUSBAND TRIED TO WAKE HER UP, BUT SHE WASN'T RESPONDING TO HIM. HER HUSBAND CALLED THE PARAMEDICS AROUND 3 OR 4 AM. SHE SAID THE PARAMEDICS USED THEIR METER TO TEST HER GLUCOSE AND THEY RECEIVED 42. THEY GAVE HER SOMETHING TO HELP INCREASE HER GLUCOSE. SHE STARTED TO COME BACK TO HER NORMAL SELF AFTER THEY TREATED HER. SHE STORES METER IN HER BEDROOM. CUSTOMER IS NOT RECEIVING OXYGEN THERAPY. SHE DOESN'T HAVE TROUBLE GETTING A SAMPLE OF BLOOD AND SEALS STRIP BOTTLE TIGHTLY AND IMMEDIATELY AFTER OPENING. USES FINGERTIP AS A TESTING SITE. USES ALCOHOL TO CLEANSE TESTING SITE AND ALLOWS HANDS TO DRY THOROUGHLY. OPENED TEST STRIP BOTTLE LAST MONTH. VERIFIED THERE'S NO CHANGES IN DIET, EXERCISE OR STRESS LEVELS. VERIFIED SHE CHANGE THE LANCET
Patient problems: Hypoglycemia
MAUDE report 11639863 ↗InjuryFeb 25, 2021High Readings; High Readings
METER IS LESS THAN TWO MONTHS OLD. METER, TEST STRIPS AND LANCING DEVICE STORED IN THE POUCH IN A DRAWER IN HIS BEDROOM. HAS BEEN A DIABETIC AWHILE. AT THE TIME OF THIS CALL, THE METER'S DATE AND TIME WERE NOT ACCURATE AND WERE SHOWING (B)(6) 2021, NOT (B)(6) 2021. HAD BEEN DOING A SIDE-BY-SIDE TEST WITH A CONTINUANCE BLOOD SUGAR TESTING SYSTEM (LIBRE) AT THE SAME TIME AS USING THIS METER PER DOCTOR'S REQUEST. THE LIBRE WAS SHOWING HIM ALONG HIS LOWER RUNGS, WHILE THE EXPRESSION METER AT THE SAME TIME WAS SHOWING HIM HIGH. HE DOES HAVE A RECENT A1C TEST RESULT OF 5.7 AND PREVIOUS ONES OF 5.5. HE WAS TAKING ADDITIONAL READINGS DURING THE WEEK. CUSTOMER WAS NOTICING SOME FLUCTUATIONS IN THE READINGS DURING THE WEEK. AROUND 8 PM ON (B)(6) 2021 HE RECEIVED A READING OF ALMOST 400. HE HAD NOT TAKEN HIS LONG-TERM INSULIN YET. HE NORMALLY TAKES THAT AROUND 10-11 PM AT NIGHT WHEN HE IS GOING TO BED. HE TOOK SOME ADDITIONAL SHORT-TERM INSULIN, WHICH HE HAD INITIALLY TAKEN AT ABOUT 7 PM WHEN HE HAD DINNER. IN THE EARLY MORNING, HE WAS STILL CONCERNED SO HE TOOK SOME ADDITIONAL READINGS WHICH WERE IN THE 300-400 RANGE. HE TOOK SOME MORE SHORT-TERM INSULIN SINCE IT WAS NOT GOING DOWN. CALLER S
Patient problems: Hypoglycemia
MAUDE report 11382758 ↗InjuryFeb 3, 2021High Readings; High Readings
METER IS LESS THAN TWO MONTHS OLD. METER, TEST STRIPS, AND LANCING DEVICE STORED IN THE POUCH IN A DRAWER IN HIS BEDROOM. HAS BEEN A DIABETIC AWHILE. AT THE TIME OF THIS CALL, THE METER'S DATE AND TIME WERE NOT ACCURATE AND WERE SHOWING (B)(6) 2021, NOT (B)(6) 2021. HAD BEEN DOING A SIDE-BY-SIDE TEST WITH A CONTINUANCE BLOOD SUGAR TESTING SYSTEM (LIBRE) AT THE SAME TIME AS USING THIS METER PER DOCTOR'S REQUEST. THE LIBRE WAS SHOWING HIM ALONG HIS LOWER RUNGS, WHILE THE EXPRESSION METER AT THE SAME TIME WAS SHOWING HIM HIGH. HE DOES HAVE A RECENT A1C TEST RESULT OF 5.7 AND PREVIOUS ONES OF 5.5. HE WAS TAKING ADDITIONAL READINGS DURING THE WEEK. CUSTOMER WAS NOTICING SOME FLUCTUATIONS IN THE READINGS DURING THE WEEK. AROUND 8 PM ON (B)(6) 2021 HE RECEIVED A READING OF ALMOST 400. HE HAD NOT TAKEN HIS LONG-TERM INSULIN YET. HE NORMALLY TAKES THAT AROUND 10-11 PM AT NIGHT WHEN HE IS GOING TO BED. HE TOOK SOME ADDITIONAL SHORT-TERM INSULIN, WHICH HE HAD INITIALLY TAKEN AT ABOUT 7 PM WHEN HE HAD DINNER. IN THE EARLY MORNING, HE WAS STILL CONCERNED SO HE TOOK SOME ADDITIONAL READINGS WHICH WERE IN THE 300-400 RANGE. HE TOOK SOME MORE SHORT-TERM INSULIN SINCE IT WAS NOT GOING DOWN. CALLER
Patient problems: Hypoglycemia
MAUDE report 11274281 ↗InjuryOct 23, 2020High Readings; High Readings
CALLER GOT READY FOR DAY, AND THEN SHE STARTED SHAKING, AND HAVING HYPOGLYCEMIA SYMPTOMS, SO SHE CHECKED HER BLOOD GLUCOSE AND RECEIVED A READING OF 145. SHE DID A CONTROL SOLUTION TEST THAT WAS IN RANGE. SHE CALLED HER GRANDDAUGHTER AND CALLED 911 AND THE EMS CAME ABOUT 15 MINUTES LATER. THEY CHECKED HER BLOOD GLUCOSE AND IT WAS 97, SO THEY TREATED HER WITH A GLUCOSE IV AND WITHIN TWO MINUTES SHE STOPPED SHAKING. SHE THEN HAD HER GRANDDAUGHTER TAKE HER TO THE HOSPITAL TO GET CHECKED OUT. AT THE HOSPITAL, A FEW TESTS WERE PERFORMED, AND THEY RELEASED HER WITHOUT ANY TREATMENT OF ANY SORT. CALLER ALSO STATED SHE HAS NEVER FELT LIKE THIS BEFORE OR EXPERIENCED THIS BEFORE.
Patient problems: Hypoglycemia
MAUDE report 10723951 ↗InjurySep 21, 2020High Readings; High Readings
CUSTOMER'S WIFE WAS CALLING TO REPORT THAT THE METER WAS READING TOO HIGH. READING IS TOO HIGH BASED ON SYMPTOMS DISPLAYED AND CALLER STATED IF READING WAS ACCURATE, CUSTOMER WOULDN'T HAVE BEEN DISPLAYING SYMPTOMS. PATIENT WAS EATING LUNCH AND TOOK INSULIN ON HIS PUMP. THEN HE CALLED TO HIS WIFE AND ASKED FOR HELP AS HE WAS EXPERIENCING SEVERE HYPOGLYCEMIC SYMPTOMS AND HAVING A HARD TIME TALKING. HE WAS THEN CHECKED ON THE EXPRESSION METER AND THE READING WAS 50. HE WAS THEN CHECKED ON HIS BAYER METER AND THE READING WAS 31. HE WAS GIVEN JUICE AND GLUCOSE GEL AFTER 15 MINUTES HE WAS STILL VERY LOW, AND THE PARAMEDICS WERE CALLED. HE WAS GIVEN MORE GLUCOSE GEL FROM THEM AND IT TOOK TWO HOURS TO GET HIS BLOOD SUGAR UP. HE WAS NOT TAKEN TO THE HOSPITAL.
Patient problems: Hypoglycemia
MAUDE report 10564824 ↗InjuryAug 28, 2020High Readings; High Readings
CUSTOMER'S WIFE WAS CALLING TO REPORT THAT THE METER WAS READING TOO HIGH. READING IS TOO HIGH BASED ON SYMPTOMS DISPLAYED AND CALLER STATED IF THE READING WAS ACCURATE, CUSTOMER WOULDN'T HAVE BEEN DISPLAYING SYMPTOMS. PATIENT WAS EATING LUNCH AND TOOK INSULIN ON HIS PUMP. THEN HE CALLED TO HIS WIFE AND ASKED FOR HELP AS HE WAS EXPERIENCING SEVERE HYPOGLYCEMIC SYMPTOMS AND HAVING A HARD TIME TALKING. HE WAS THEN CHECKED ON THE EXPRESSION METER AND THE READING WAS 50. HE WAS THEN CHECKED ON HIS BAYER METER AND THE READING WAS 31. HE WAS GIVEN JUICE AND GLUCOSE GEL AFTER 15 MINUTES HE WAS STILL VERY LOW, AND THE PARAMEDICS WERE CALLED. HE WAS GIVEN MORE GLUCOSE GEL FROM THEM AND IT TOOK TWO HOURS TO GET HIS BLOOD SUGAR UP. HE WAS NOT TAKEN TO THE HOSPITAL. REPLACED METER, STRIPS, SENT CS AND RL.
Patient problems: Hypoglycemia
MAUDE report 10465269 ↗InjuryAug 28, 2020High Readings; High Readings
CALLER GOT READY FOR DAY, AND THEN SHE STARTED SHAKING, AND HAVING HYPOGLYCEMIA SYMPTOMS, SO SHE CHECKED HER BLOOD GLUCOSE AND RECEIVED A READING OF 145. SHE DID A CS TEST THAT WAS IN RANGE. SHE CALLED HER GRANDDAUGHTER AND CALLED 911 AND THE EMS CAME ABOUT 15 MINUTES LATER. THEY CHECKED HER BLOOD GLUCOSE AND IT WAS 97, SO THEY TREATED HER WITH A GLUCOSE IV AND WITHIN TWO MINUTES SHE STOPPED SHAKING. SHE THEN HAD HER GRANDDAUGHTER TAKE HER TO THE HOSPITAL TO GET CHECKED OUT. AT THE HOSPITAL, A FEW TESTS WERE PERFORMED, AND THEY RELEASED HER WITHOUT ANY TREATMENT OF ANY SORT. CALLER ALSO STATED SHE HAS NEVER FELT LIKE THIS BEFORE OR EXPERIENCED THIS BEFORE. REPLACED METER, STRIPS, SENT CS AND RETURN LABEL.
Patient problems: Hypoglycemia
MAUDE report 10465199 ↗MalfunctionFeb 27, 2020Missing Test Results; Missing Test Results
CUSTOMER CALLED BECAUSE HIS WIFE WAS RECEIVING VARIANCES WHEN PERFORMING A BLOOD TEST. THE READINGS SHE RECEIVED WERE AROUND LUNCH TIME. SHE STATED THE READING WAS LO, THEN A FEW MINUTES LATER RECEIVED 302, THEN AGAIN RECEIVED 289. THESE READINGS WERE IN B & C ZONES PER PARKES GRID. CUSTOMER STATED THAT EACH READING WAS ONE MINUTE A PART. EL573427. LOT B4S1903003 - 2020-12-05 - 50CT. OPENED TEST STRIPS ABOUT A MONTH OR LESS AGO. CUSTOMER IS NOT RECEIVING ANY OXYGEN THERAPY. CALLER DOESN'T HAVE TROUBLE GETTING A SAMPLE OF BLOOD BUT ONE TIME A WEEK SHE'LL GET AN ERROR MESSAGE THAT THERE'S NOT ENOUGH BLOOD. WASHES HER HANDS WITH SOAP AND WATER. SHE ALSO USES ALCOHOL WIPES. CALLER DOESN'T CHANGE THE LANCETS EVERY TIME SHE TESTS. SHE STORES IN THE DINING ROOM ABOUT 20 FEET FROM THE KITCHEN AND THERE'S A DIVIDER BETWEEN THE ROOMS. SEALS BOTTLE CAP TIGHTLY AND IMMEDIATELY AFTER REMOVING A STRIP. CUSTOMER DOESN'T HAVE CONTROL SOLUTION. SHE USES FINGERTIP AS A TESTING SITE. I WALKED THE CUSTOMER THROUGH A BLOOD TEST, AND SHE RECEIVED A READING OF 276. REPLACED METER, STRIPS AND SENT RETURN LABEL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9762042 ↗InjuryFeb 27, 2020High Test Results; High Test Results
PATIENT'S BROTHER-IN-LAW (B)(6) IS CALLING REGARDING PATIENT WHO IS RECEIVING EMERGENCY MEDICAL TREATMENT AT TIME OF CALL. BROTHER-IN-LAW HEARD NOISE IN HIS BEDROOM, ROOMMATE WENT IN AND PATIENT WAS NOT RESPONSIVE. CALLER IS STATING METER HAS GIVEN HIM FALSE READINGS. AMBULANCE WAS CALLED AND PATIENT'S BLOOD SUGAR WAS READING 20 WITH AMBULANCE METER. AMBULANCE PERSONNEL GAVE CUSTOMER ORANGE JUICE AND ADVISED FAMILY MEMBERS TO GIVE HIM SOMETHING TO EAT. THE PATIENT WAS NOT TAKEN TO THE HOSPITAL. THE EMERGENCY PERSONNEL ADVISED FAMILY MEMBERS TO CALL FOR A NEW METER. PATIENT WAS TAKING A BLOOD TEST WITH HIS EXPRESSION METER AND IT READ 61. IT WAS VERIFIED WITH CALLER THAT PATIENT IS USING CORRECT TECHNIQUE APPLYING THE BLOOD. ADVISED CALLER TO HAVE PATIENT TEST AGAIN WITH SAME HAND, DIFFERENT FINGER SO WE CAN CHECK FOR A VARIANCE. PATIENT IS HAVING A HARD TIME GETTING BLOOD AND FAMILY MEMBERS ARE ADVISING HIM TO SQUEEZE HIS FINGER. ADVISED AGAINST SQUEEZING FINGER TO PROVIDE MORE BLOOD BUT FAMILY MEMBER WAS NOT TAKING ADVICE. CALLER IS NOW TESTING PATIENT WITH HIS METER AND REFUSING TO DO ANOTHER TEST WITH THE PATIENT'S EXPRESSION METER SAYING IT IS DEFECTIVE AND TO SEND ANOTHER ONE
Patient problems: Hypoglycemia
MAUDE report 9760789 ↗InjuryFeb 7, 2020High Test Results; High Test Results
PATIENT'S BROTHER-IN-LAW (B)(6) IS CALLING REGARDING PATIENT WHO IS RECEIVING EMERGENCY MEDICAL TREATMENT AT TIME OF CALL. BROTHER-IN-LAW HEARD NOISE IN HIS BEDROOM, ROOMMATE WENT IN AND PATIENT WAS NOT RESPONSIVE. CALLER IS STATING METER HAS GIVEN HIM FALSE READINGS. AMBULANCE WAS CALLED AND PATIENT'S BLOOD SUGAR WAS READING 20 WITH AMBULANCE METER. AMBULANCE PERSONNEL GAVE CUSTOMER ORANGE JUICE AND ADVISED FAMILY MEMBERS TO GIVE HIM SOMETHING TO EAT. THE PATIENT WAS NOT TAKEN TO THE HOSPITAL. THE EMERGENCY PERSONNEL ADVISED FAMILY MEMBERS TO CALL FOR A NEW METER. PATIENT WAS TAKING A BLOOD TEST WITH HIS EXPRESSION METER AND IT READ 61. IT WAS VERIFIED WITH CALLER THAT PATIENT IS USING CORRECT TECHNIQUE APPLYING THE BLOOD. ADVISED CALLER TO HAVE PATIENT TEST AGAIN WITH SAME HAND, DIFFERENT FINGER SO WE CAN CHECK FOR A VARIANCE. PATIENT IS HAVING A HARD TIME GETTING BLOOD AND FAMILY MEMBERS ARE ADVISING HIM TO SQUEEZE HIS FINGER. ADVISED AGAINST SQUEEZING FINGER TO PROVIDE MORE BLOOD BUT FAMILY MEMBER WAS NOT TAKING ADVICE. CALLER IS NOW TESTING PATIENT WITH HIS METER AND REFUSING TO DO ANOTHER TEST WITH THE PATIENT'S EXPRESSION METER SAYING IT IS DEFECTIVE AND TO SEND ANOTHER ONE
Patient problems: Hypoglycemia
MAUDE report 9680967 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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.
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