GLUCOCARD® Shine BLOOD GLUCOSE TEST STRIPS 542050Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00015482540500), received between Jul 20, 2020 and Oct 14, 2022 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Low Readings” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2022High Readings; High Readings

  THE CUSTOMER PURCHASED A SHINE XL METER ON (B)(6) 2022. THE CUSTOMER BEGAN USING THE NEW METER ON (B)(6) 2022. PRIOR TO PURCHASING THE SHINE XL METER, THE CUSTOMER USED A CONTOUR NEXT METER. THE READINGS THE CUSTOMER RECEIVES ON THE SHINE XL METER ARE MUCH HIGHER THAN THE READINGS THAT HE RECEIVED ON HIS OLD METER. THE CUSTOMER STATED THAT HE RECEIVED READINGS OF 479 AND 411 ON THE SHINE XL METER. THE CUSTOMER HAD BEEN FASTING PRIOR TO TESTING. THE CUSTOMER CLAIMS THAT THIS IS CAUSING HIM TO TAKE MORE UNITS OF INSULIN THAN NEEDED. THE CUSTOMER HAS NOT ACTUALLY BEEN HOSPITALIZED DUE TO THIS, BUT HE HAS BEEN IN COMMUNICATION WITH HIS DOCTOR BY PHONE. HIS DOCTOR HAS ADVISED HIM TO GO TO THE ER DUE TO THE HIGH READINGS. THE CUSTOMER STATES HE WAS NOT ABLE TO GO TO THE ER DUE TO A LACK OF TRANSPORTATION AND HE DID NOT FEEL SAFE TO DRIVE ON HIS OWN DUE TO FEELING DROWSY AND LIGHTHEADED. I PERFORMED THREE BLOOD TESTS WITH THE CUSTOMER, AND HE RECEIVED READINGS OF 164, 167, AND 151. HE STATES THAT HE SHOULD RECEIVE READINGS AROUND 98-100. CUSTOMER DOES NOT TRUST THE METER AND WOULD LIKE IT REPLACED. REPLACED METER, STRIPS, SENT CONTROL SOLUTION AND RETURN LABEL.

  Patient problems: Dizziness; Hypoglycemia

  MAUDE report 15603156 ↗
• InjuryOct 13, 2022High Readings; High Readings

  THE CUSTOMER PURCHASED A SHINE XL METER ON (B)(6) 2022. THE CUSTOMER BEGAN USING THE NEW METER ON (B)(6) 2022. PRIOR TO PURCHASING THE SHINE XL METER, THE CUSTOMER USED A CONTOUR NEXT METER. THE READINGS THE CUSTOMER RECEIVES ON THE SHINE XL METER ARE MUCH HIGHER THAN THE READINGS THAT HE RECEIVED ON HIS OLD METER. THE CUSTOMER STATED THAT HE RECEIVED READINGS OF 479 AND 411 ON THE SHINE XL METER. THE CUSTOMER HAD BEEN FASTING PRIOR TO TESTING. THE CUSTOMER CLAIMS THAT THIS IS CAUSING HIM TO TAKE MORE UNITS OF INSULIN THAN NEEDED. THE CUSTOMER HAS NOT ACTUALLY BEEN HOSPITALIZED DUE TO THIS, BUT HE HAS BEEN IN COMMUNICATION WITH HIS DOCTOR BY PHONE. HIS DOCTOR HAS ADVISED HIM TO GO TO THE ER DUE TO THE HIGH READINGS. THE CUSTOMER STATES HE WAS NOT ABLE TO GO TO THE ER DUE TO A LACK OF TRANSPORTATION AND HE DID NOT FEEL SAFE TO DRIVE ON HIS OWN DUE TO FEELING DROWSY AND LIGHTHEADED. I PERFORMED THREE BLOOD TESTS WITH THE CUSTOMER, AND HE RECEIVED READINGS OF 164, 167, AND 151. HE STATES THAT HE SHOULD RECEIVE READINGS AROUND 98-100. CUSTOMER DOES NOT TRUST THE METER AND WOULD LIKE IT REPLACED. REPLACED METER, STRIPS, SENT CONTROL SOLUTION AND RETURN LABEL.

  Patient problems: Dizziness; Hypoglycemia

  MAUDE report 15595036 ↗
• InjuryMay 10, 2021Low Readings; Low Readings

  CALLER (PATIENT'S NEPHEW) STATES THAT HIS AUNT HAS 24-HOUR CARE, SO SHE IS NOT TESTING HERSELF, BUT HER IN-HOME CARE STAFF TESTS HER BLOOD GLUCOSE. CALLER DID TWO TESTS; ONE WITH THE GLUCOCARD SHINE XL AND RECEIVED A READING OF 98, AND ONE WITH THEIR METER AND RECEIVED 309, WHICH MADE THEM BELIEVE THE PATIENT'S METER (THE GLUCOCARD SHINE XL) WAS NOT WORKING CORRECTLY. PATIENT WAS ALERT, BUT CALLER STATED SHE WAS ACTING SOMEWHAT ERRATIC, SO HE DECIDED TO CALL THE PARAMEDICS. PARAMEDICS WERE CALLED AND WHEN THE PARAMEDICS CAME, THEY CHECKED THE PATIENT'S BLOOD GLUCOSE WITH THEIR METER AND THE READING WAS 487. PATIENT WAS BROUGHT TO THE HOSPITAL. WHILE THE PATIENT IS CURRENTLY STILL AT THE HOSPITAL, THE CALLER CONTACTED US, AND WE DID TWO CS TESTS WITH THEM OVER THE PHONE AND WALKED THEM THROUGH THE STEPS AND THEY RECEIVED A RESULT OF 86 BOTH TIMES AND THE L1 CS RANGE IS 115-156. PATIENT'S BLOOD GLUCOSE WAS UNDER CONTROL IN THE HOSPITAL, AND SHE ALSO HAD OTHER MEDICAL ISSUES THAT NEEDED TO BE ADDRESSED. I EXPLAINED TO THE CALLER THAT I WAS GOING TO REPLACE THE PATIENT'S METER, TEST STRIPS AND CS. I INFORMED THE CUSTOMER I WOULD GET THAT ORDERED TODAY AND IT WOULD GET SHIPPED ON 3/17/2

  Patient problems: Hyperglycemia

  MAUDE report 11798847 ↗
• InjuryApr 15, 2021Low Readings; Low Readings

  CALLER (PATIENT'S NEPHEW) STATES THAT HIS AUNT HAS 24-HOUR CARE, SO SHE IS NOT TESTING HERSELF, BUT HER IN-HOME CARE STAFF TESTS HER BLOOD GLUCOSE. CALLER DID TWO TESTS; ONE WITH THE GLUCOCARD SHINE XL AND RECEIVED A READING OF 98MG/DL, AND ONE WITH THEIR METER AND RECEIVED 309MG/DL, WHICH MADE THEM BELIEVE THE PATIENT'S METER (THE GLUCOCARD SHINE XL) WAS NOT WORKING CORRECTLY. PATIENT WAS ALERT, BUT CALLER STATED SHE WAS ACTING SOMEWHAT ERRATIC, SO HE DECIDED TO CALL THE PARAMEDICS. PARAMEDICS WERE CALLED AND WHEN THE PARAMEDICS CAME, THEY CHECKED THE PATIENT'S BLOOD GLUCOSE WITH THEIR METER AND THE READING WAS 487MG/DL. PATIENT WAS BROUGHT TO THE HOSPITAL. WHILE THE PATIENT IS CURRENTLY STILL AT THE HOSPITAL, THE CALLER CONTACTED US, AND WE DID TWO CONTROL SOLUTION TESTS WITH THEM OVER THE PHONE AND WALKED THEM THROUGH THE STEPS AND THEY RECEIVED A RESULT OF 86MG/DL BOTH TIMES AND THE L1 CONTROL SOLUTION RANGE IS 115-156MG/DL. PATIENT'S BLOOD GLUCOSE WAS UNDER CONTROL IN THE HOSPITAL, AND SHE ALSO HAD OTHER MEDICAL ISSUES THAT NEEDED TO BE ADDRESSED.

  Patient problems: Hyperglycemia

  MAUDE report 11676222 ↗
• MalfunctionMar 26, 2021Low Test Results; Low Test Results

  CUSTOMER CALLED TO KNOW HOW TO PERFORM A CONTROL SOLUTION TEST. WE DID THE TEST TOGETHER ON HIS SOLUTION THAT HE JUST OPENED. THE READING WAS 78MG/DL WHICH WAS BELOW THE RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573618 ↗
• MalfunctionNov 25, 2020Low Test Results; Low Test Results

  PATIENT HAS BEEN RECEIVING A BUNCH OF ERRATIC READINGS DURING THE PAST SEVERAL DAYS. PATIENT IS NORMALLY STABLE WITH READINGS. FIRST INCIDENT WAS ON WEDNESDAY NIGHT (B)(6) 2020 WHEN SHE RECEIVED 34MG/DL AFTER TAKING MEDICATION TWO HOURS AFTER DINNER. PATIENT THEN TOOK A GLUCOSE TABLET, AND IT WENT UP TO 197MG/DL. ON (B)(6) 2020, THE READINGS KEPT FLUCTUATING BACK AND FORTH. PATIENT SAID ON (B)(6) 2020, THE READINGS DID NOT FLUCTUATE TOO MUCH. PATIENT AGAIN HAD A LOW READING ON (B)(6) 2020 AND RECEIVED 24MG/DL AT 8:55 AM. PATIENT RECEIVED A 52MG/DL AND THEN ATE A GLUCERNA BAR WHICH INCREASED IT TO 160MG/DL. PATIENT WAS NOT SURE WHAT HER ACTUAL BLOOD GLUCOSE WAS, SO SHE DID GO TO THE EMERGENCY ROOM WHERE SHE RECEIVED A LO READING WHILE IN THE EMERGENCY ROOM ON THE GLUCOCARD SHINE XL METER. PATIENT WAS TESTED AT THE EMERGENCY ROOM WITH THEIR METER SYSTEM AND RECEIVED A READING OF 141MG/DL. PATIENT WAS NOT TREATED AT THE EMERGENCY ROOM. SHE MAINLY WENT THERE TO FIND OUT WHAT HER BLOOD GLUCOSE WAS. SHE FELT FINE AND WENT HOME. PATIENT OPENED A BOTTLE OF NEW TEST STRIPS ON (B)(6) 2020. THE METER WAS PURCHASED IN (B)(6) OF 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10902974 ↗
• MalfunctionOct 29, 2020Low Test Results; Low Test Results

  CUSTOMER JUST RECEIVED A GLUCOCARD SHINE XL METER RECENTLY AND HAS ONLY RECEIVED READINGS OF 80MG/DL IN THE 10 TESTS THEY HAVE DONE. CUSTOMER DID A CONTROL SOLUTION TEST AND THIS CAME BACK AS 80MG/DL AS WELL, WHICH IS OUTSIDE THE RANGE ON THEIR BOTTLE. I TOLD CUSTOMER WE CAN REPLACE THE METER AND ALL OTHER PRODUCTS USED INCLUDING TEST STRIPS AND CONTROL SOLUTION. I EXPLAINED THE RETURN PROCESS AS WE WOULD LIKE THESE BACK FOR TESTING. I ALSO EXPLAINED THE SHIPPING TIMES AND TOLD THEM TO CALL BACK IF THEY DO NOT RECEIVE IT IN 3-5 BUSINESS DAYS. CUSTOMER HAD NO FURTHER QUESTIONS FOR ME. REPLACED METER, STRIPS, CS AND SENT RL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10753566 ↗
• MalfunctionAug 7, 2020Incorrect Measurement; Low Readings; Incorrect Measurement; Low Readings

  CALLER HAS OWNED METER FOR TWO WEEKS. CUSTOMER SAYS SHE KEEPS RECEIVING THE SAME NUMBER WHEN SHE PERFORM A BLOOD TEST. I ASKED HER TO INSERT A NEW STRIP INTO METER WHILE METER IS OFF AND METER POWERED ON WITH THE FLASHING DROP. I ASKED HER IF SHE WOULD LIKE TO PERFORM A BLOOD TEST WITH ME AND SHE SAID YES. I ASKED HER TO PERFORM HER FINGER POKE AND GET THE BLOOD READY BUT NOT TO DO ANYTHING ELSE. THEN EXPLAINED SHE WANTS TO HOLD METER SO THAT STRIP IS POINTING TO THE FLOOR THEN TO HOLD STRIP END IN THE BLOOD FOR THREE SECONDS WITHOUT TOUCHING THE SKIN. SHE DID SO AND RECEIVED A READING OF 89MG/DL. SHE SAYS SHE KEEPS GETTING THAT NUMBER EVEN THOUGH SHE DOES NOT FEEL LIKE IT. I ASKED WHERE SHE STORES METER AND STRIPS AND SHE SAYS NEAR THE KITCHEN ON THE COUNTER TOP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10377602 ↗
• MalfunctionAug 7, 2020Incorrect Measurement; Low Readings; Non Reproducible Results; Incorrect Measurement; Low Readings; Non Reproducible Results

  CUSTOMER IS NOT RECEIVING ANY OXYGEN THERAPY. CUSTOMER DOESN'T HAVE TROUBLE GETTING A SAMPLE OF BLOOD. CUSTOMER DOESN'T CHANGE HER LANCETS EVERY TIME SHE TESTS. SHE CHANGED LANCETS ONCE OR TWICE A WEEK. STORES IN HER BEDROOM. WASHES HANDS WITH SOAP AND WATER AND ALCOHOL. ALLOWS HANDS TO DRY THOROUGHLY. USES FINGERTIP AS A TESTING SITE. RECEIVED 126MG/DL AND 76MG/DL WHICH IS A 39% VARIANCE. WALKED CUSTOMER THROUGH A CONTROL SOLUTION TEST AND IT TESTED OUSIDE THE RANGE. CS READING IS 79MG/DL IN L1 RANGE OF 114-154MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10377599 ↗
• MalfunctionJul 20, 2020Incorrect Measurement; Low Readings; Incorrect Measurement; Low Readings

  CALLER HAS OWNED METER SINCE FEBRUARY. CUSTOMER SAYS NO MATTER WHAT SHE DOES, METER WILL ALWAYS GIVE A READING OF 95MG/DL. SHE SAYS SHE KNOWS HOW TO USE THE METER. I ASKED HER IF SHE WOULD LIKE TO PERFORM A BLOOD TEST WITH ME AND SHE SAID SHE HAD JUST DONE IT SINCE SHE WAS OUT WORKING ALL DAY AND READING WAS ONCE AGAIN 95MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10299811 ↗