Sidekick Sidekick All-In-One Blood Glucose Monitoring SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00021292012823), received between Oct 13, 2020 and Sep 9, 2022 — classified as 2 injuries, 3 malfunctions.

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

• InjurySep 9, 2022Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR LOW BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 77 AND 84 MG/DL FASTING. THE CUSTOMER DOES NOT KNOW THEIR EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. AT THE TIME OF THE CALL THE CUSTOMER REPORTED FEELING LIGHTHEADED; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. DURING THE CALL, A BLOOD TEST WAS PERFORMED BY THE CUSTOMER NON-FASTING AND PRODUCED TEST RESULT OF 92 MG/DL USING SIDEKICK METER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE DINING ROOM. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 10/31/2023 AND OPEN VIAL DATE IS (B)(6) 2022. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY; CUSTOMER DID PROVIDE DATE/TIME FOR THE RESULTS OF CONCERN: RESULT: 77 MG/DL ; DATE: (B)(6) 2022 ; TIME: 9:22 AM FASTING. RESULT : 84 MG/DL ; DATE: (B)(6) 2022 ; TIME: 9:40 AM FASTING.

  Patient problems: Presyncope

  MAUDE report 15392224 ↗
• InjuryJun 21, 2022Low Test Results; Low Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH AND LOW BLOOD GLUCOSE TEST RESULTS. CUSTOMER STATED THAT SHE WAS OBTAINING HIGH RESULTS WITH ANOTHER SIDEKICK METER: ADDITIONAL REPORT REFERENCE NUMBER (B)(4). THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 42MG/DL AM NON-FASTING. THE CUSTOMER DID NOT PROVIDE ANY HIGH RESULTS OF CONCERN. THE CUSTOMER¿S EXPECTED AM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 116-200MG/DL, EXPECTED PM FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 175-210MG/DL AND EXPECTED BEDTIME FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 102-201MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. CUSTOMER STATED THAT AT LEAST 5 OR 6 TIMES SHE HAS GIVEN HERSELF TO MUCH INSULIN DUE TO HER METER READING HIGHER THAN NORMAL AM FASTING. CUSTOMER STATED THAT LAST FRIDAY, (B)(6) 2022 OR SATURDAY, (B)(6) 2022 (SHE DOESN'T RECALL THE EXACT DATE) SHE GAVE HERSELF TO MUCH INSULIN AND THAT SHE ALMOST PASSED OUT. CUSTOMER STATED SHE WAS FEELING NAUSEOUS AND WEAK. CUSTOMER STATED THAT SHE ATE SOMETHING AND THEN SHE FELT A LITTLE BIT BETTER AND THEN SHE TESTED HER BLOOD SUGAR AND RESULT WAS 42MG/DL NON-FASTING AM. CUSTOMER STATED SHE CALLED HER NEIGHBOR TO LET HER KN

  Patient problems: Muscle Weakness/Atrophy; Nausea; Presyncope

  MAUDE report 14755587 ↗
• MalfunctionMar 29, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  CONSUMER REPORTED COMPLAINT FOR PHYSICAL DEFECT OF TEST STRIPS, STATING THAT THE TEST STRIPS WITH THE SIDEKICK METER WERE STICKING TOGETHER. CUSTOMER STATED THAT SHE HAS TO SEPARATE THE TEST STRIPS WHEN SHE TRIES TO TEST. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/22/2023; OPEN VIAL DATE AND PRODUCT STORAGE WERE NOT DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939059 ↗
• MalfunctionJul 22, 2021High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF 299MG/DL. CUSTOMER ALSO STATED RESULTS OBTAINED USING THE SIDEKICK METER WERE HIGHER WHEN COMPARED TO ANOTHER DEVICE; ACTUAL METER TO METER COMPARISON RESULTS WERE NOT PROVIDED. THE CUSTOMER¿S EXPECTED EVENING FASTING BLOOD GLUCOSE TEST RESULT RANGE IS 101-110MG/DL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. DURING THE CALL, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 06/22/2023 AND STORAGE LOCATION AND OPEN VIAL DATE ARE UNKNOWN. CUSTOMER HAD PURCHASED THE PRODUCTS FROM AN ONLINE DISTRIBUTOR. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY: (B)(6).

  Patient problems: Hyperglycemia

  MAUDE report 12215066 ↗
• MalfunctionOct 13, 2020Material Integrity Problem; Material Integrity Problem

  CONSUMER REPORTED COMPLAINT FOR PHYSICAL DEFECTS OF STRIPS. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 01/31/2021 AND OPEN VIAL DATE IS UNDISCLOSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10671473 ↗