Prodigy Voice Blood Glucose Monitoring System 051900Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00384840519008), received between Apr 25, 2018 and Sep 11, 2019 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (6 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.

• InjurySep 11, 2019Low Test Results; Low Test Results

  END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 7:30 PM AT HIS HOME. END-USER STATED THAT HE WAS AWAKE BUT NOT RESPONDING TO VERBAL COMMANDS AND HIS SPEECH WAS SLURRING. HE WAS TESTED WITH HIS PRODIGY METER AND GOT A RESULT OF 35 MG/DL WHICH PROMPTED HIS WIFE TO CALL EMS. NO MEDICATIONS OR FOOD WAS CONSUMED BY THE END-USER WHILE WAITING FOR THE EMS TO ARRIVE. PARAMEDICS ARRIVED WITHIN APPROXIMATELY 5 MINUTES, AND WHEN TESTED WITH THE EMS METER HIS BLOOD GLUCOSE WAS 50 MG/DL. THE PARAMEDICS ADMINISTERED A GLUCOSE IV AND TRANSPORTED HIM TO THE HOSPITAL. THE ENDUSER WAS STATED THAT UPON ARRIVING AT THE HOSPITAL HIS BLOOD GLUCOSE WAS AROUND 35-45 MG/DL. THE DR AT THE HOSPITAL GAVE THE ENDUSER ANOTHER SHOT OF A GLUCOSE SOLUTION AND HE ATE A TURKEY SANDWICH APPLE JUICE AND 2 CONTAINERS OF VANILLA PUDDING. PRIOR TO DISCHARGE THE END-USERS BLOOD GLUCOSE WAS 102 MG/DL. HE WAS NOT ADMITTED AND WAS DISCHARGED AFTER ABOUT 3 HOURS FROM (B)(6) HEALTHCARE LOCATED AT (B)(6). THE TEST STRIPS THE CALLER WAS USING DURING THE DATE OF THE MEDICAL ATTENTION HAVE RED DESICCANTS, INDICATING THAT THE TS MAY HAVE BEEN EXPOSED TO HUMIDITY OR MOISTURE.

  Patient problems: Confusion/ Disorientation; Hypoglycemia

  MAUDE report 8987595 ↗
• InjuryAug 25, 2019High Test Results; High Test Results

  IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019. REPORTER STATED THAT HER FATHER HAS BEEN TO THE EMERGENCY ROOM DUE THE FALSE HIGH RESULTS. CALLER STATED SHE CALLED EMS DUE TO HER FATHER HAVING LOW BLOOD GLUCOSE, BUT HIS METER DID NOT GIVE HIM A LOW RESULT. SHE STATED THAT SHE CALLED EMS AND THEY TESTED WITH THEIR METER AND RECEIVED A RESULT LOWER THAN 20 AND WHEN THEY TESTED HIM ON HIS PRODIGY METER THEY GOT A RESULT OF 111 MG/DL. CALLER STATED THAT HE WAS TRANSPORTED TO THE HOSPITAL. THE CALLER DID NOT GIVE ANY INFORMATION ON THE EMERGENCY ROOM VISIT SHE STATED SHE THREW AWAY ALL HIS PRODIGY PRODUCTS. THE CALLER ALSO STATED THAT SHE WAS COMPARING HER FATHERS PRODIGY METER TO A CONTOUR AND THE PRODIGY GAVE HIGHER RESULTS. CALLER DID NOT PROVIDE ANY MEDICATIONS PREEXISTING CONDITIONS OR ANY OTHER INFORMATION.

  Patient problems: Hypoglycemia

  MAUDE report 8928983 ↗
• InjuryAug 13, 2019Low Test Results; Low Test Results

  END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 7:30PM AT HIS HOME. END-USER STATED THAT HE WAS AWAKE BUT NOT RESPONDING TO VERBAL COMMANDS AND HIS SPEECH WAS SLURRING. HE WAS TESTED WITH HIS PRODIGY METER AND GOT A RESULT OF 35 MG/DL WHICH PROMPTED HIS WIFE TO CALL EMS. NO MEDICATIONS OR FOOD WAS CONSUMED BY THE END-USER WHILE WAITING FOR THE EMS TO ARRIVE. PARAMEDICS ARRIVED WITHIN APPROXIMATELY 5 MINUTES, AND WHEN TESTED WITH THE EMS METER HIS BLOOD GLUCOSE WAS 50 MG/DL. THE PARAMEDICS ADMINISTERED A GLUCOSE IV AND TRANSPORTED HIM TO THE HOSPITAL. THE END-USER WAS STATED THAT UPON ARRIVING AT THE HOSPITAL HIS BLOOD GLUCOSE WAS AROUND 35-45MG/DL. THE DR AT THE HOSPITAL GAVE THE END-USER ANOTHER SHOT OF A GLUCOSE SOLUTION AND HE ATE A TURKEY SANDWICH, APPLE JUICE, AND 2 CONTAINERS OF VANILLA PUDDING. PRIOR TO DISCHARGE THE END-USERS BLOOD GLUCOSE WAS 102MG/DL. HE WAS NOT ADMITTED AND WAS DISCHARGED AFTER ABOUT 3 HOURS FROM (B)(6) HEALTHCARE LOCATED AT (B)(6). THE TEST STRIPS THE CALLER WAS USING DURING THE DATE OF THE MEDICAL ATTENTION HAVE RED DESICCANTS, INDICATING THAT THE TS MAY HAVE BEEN EXPOSED TO HUMIDITY OR MOISTURE.

  Patient problems: Confusion/ Disorientation; Hypoglycemia

  MAUDE report 8887964 ↗
• InjuryAug 6, 2019High Test Results; High Test Results

  THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2019-00032 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON (B)(6) 2019 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.

  Patient problems: Confusion/ Disorientation; Hypoglycemia; Shaking/Tremors

  MAUDE report 8863538 ↗
• InjuryJul 22, 2019High Test Results; High Test Results

  IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019. REPORTER STATED THAT HER FATHER HAS BEEN TO THE EMERGENCY ROOM DUE THE FALSE HIGH RESULTS. CALLER STATED SHE CALLED EMS DUE TO HER FATHER HAVING LOW BLOOD GLUCOSE, BUT HIS METER DID NOT GIVE HIM A LOW RESULT. SHE STATED THAT SHE CALLED EMS AND THEY TESTED WITH THEIR METER AND RECEIVED A RESULT LOWER THAN 20 AND WHEN THEY TESTED HIM ON HIS PRODIGY METER THEY GOT A RESULT OF 111 MG/DL. CALLER STATED THAT HE WAS TRANSPORTED TO THE HOSPITAL. THE CALLER DID NOT GIVE ANY INFORMATION ON THE EMERGENCY ROOM VISIT SHE STATED SHE THREW AWAY ALL HIS PRODIGY PRODUCTS. THE CALLER ALSO STATED THAT SHE WAS COMPARING HER FATHERS PRODIGY METER TO A CONTOUR AND THE PRODIGY GAVE HIGHER RESULTS. CALLER DID NOT PROVIDE ANY MEDICATIONS PREEXISTING CONDITIONS OR ANY OTHER INFORMATION.

  Patient problems: Hypoglycemia

  MAUDE report 8812379 ↗
• InjuryJul 10, 2019High Test Results; High Test Results

  IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 4:30PM. THE END-USER STATED THAT HE TOOK A BLOOD GLUCOSE TEST WITH HIS PRODIGY METER AND RECEIVED A 81MG/DL. HEW STATED THAT HE FELT AS THOUGH HIS BLOOD GLUCOSE WAS LOW, SO HE CALLED PARAMEDICS. A NORMAL READING FOR THE END-USER AT THAT TIME OF DAY IS AROUND 176- 200MG/DL. THE END-USER CALLED THE PARAMEDICS ABOUT 20 MINUTES AFTER TESTING. THE PARAMEDICS ARRIVED WITHIN 5 MINUTES AND TESTED HIS BLOOD GLUCOSE AND RECEIVED A RESULT OF 41MG/DL. THE END-USER STATED THAT HE TOOK 2 SUGAR PILLS WHILE WAITING FOR THE PARAMEDICS TO ARRIVE. THE END-USER WAS NOT TRANSPORTED TO THE HOSPITAL. HE HAD 2 COKES AND A PIZZA WHILE PARAMEDICS WERE THERE. END-USER WAS NOT AWARE OF WHAT HIS BLOOD GLUCOSE WAS BEFORE THE PARAMEDICS LEFT HIS HOME. HE WAS UNABLE TO PROVIDE HIS MEDICATION LIST AND ATTEMPTS WERE MADE TO RETRIEVE THIS INFORMATION BUT WERE UNSUCCESSFUL. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Blurred Vision; Hypoglycemia; Sweating

  MAUDE report 8774946 ↗
• InjuryJul 2, 2019High Test Results; High Test Results

  IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AT 2:30AM AT THE END-USER'S HOME. THE CALLER STATED THAT THE END-USER WOKE UP AND FELT ILL. HE THEN PERFORMED A BLOOD GLUCOSE TEST AND RECEIVED A 76MG/DL. REPORTER STATED THAT SHE THEN CALLED THE PARAMEDICS DUE TO HIM NOT FEELING WELL. PARAMEDICS WERE CALLED 10 MINUTES AFTER TESTING WITH HIS PRODIGY METER. REPORTER STATED THAT HE HAD APPLE JUICE AND SUGAR WHILE WAITING FOR THE PARAMEDICS TO COME THE PARAMEDICS ARRIVED ABOUT 10 MINUTES LATER AND TESTED HIS BLOOD GLUCOSE AND RECEIVED A RESULT OF 60MG/DL, THEY THEN TESTED WITH THE END-USERS PRODIGY METER AND RECEIVED A RESULT OF 86MG/DL. THE END-USER WAS NOT TRANSPORTED TO THE HOSPITAL. THE PARAMEDICS HAD HIM EAT A PEANUT BUTTER SANDWICH. THE END-USER IS ON A SLIDING SCALE THAT IS AS FOLLOWS: LANTUS: 14 UNITS IN THE MORNING AND 24 UNITS AT NIGHT. NOVALOG: 10 UNITS (SLIDING SCALE: 150-200MG/DL ADD 2 UNITS, 201-250MG/DL ADD 3 UNITS, 251-300MG/DL ADD 4 UNITS, 351-400MG/DL ADD 6 UNITS). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Confusion/ Disorientation; Hypoglycemia; Shaking/Tremors

  MAUDE report 8755339 ↗
• InjuryJul 2, 2019High Test Results; High Test Results

  IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 4:30PM. THE END-USER STATED THAT HE TOOK A BLOOD GLUCOSE TEST WITH HIS PRODIGY METER AND RECEIVED A 81MG/DL. HE STATED THAT HE FELT AS THOUGH HIS BLOOD GLUCOSE WAS LOW, SO HE CALLED PARAMEDICS. A NORMAL READING FOR THE END-USER AT THAT TIME OF DAY IS AROUND 176-200MG/DL. THE END-USER CALLED THE PARAMEDICS ABOUT 20 MINUTES AFTER TESTING. THE PARAMEDICS ARRIVED WITHIN 5 MINUTES AND TESTED HIS BLOOD GLUCOSE AND RECEIVED A RESULT OF 41MG/DL. THE END-USER STATED THAT HE TOOK 2 SUGAR PILLS WHILE WAITING FOR THE PARAMEDICS TO ARRIVE. THE END-USER WAS NOT TRANSPORTED TO THE HOSPITAL. HE HAD 2 (B)(6) AND A PIZZA WHILE PARAMEDICS WERE THERE. END-USER WAS NOT AWARE OF WHAT HIS BLOOD GLUCOSE WAS BEFORE THE PARAMEDICS LEFT HIS HOME. HE WAS UNABLE TO PROVIDE HIS MEDICATION LIST AND ATTEMPTS WERE MADE TO RETRIEVE THIS INFORMATION BUT WERE UNSUCCESSFUL. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Blurred Vision; Hypoglycemia; Sweating

  MAUDE report 8754089 ↗
• MalfunctionMay 29, 2018Corroded; Battery Problem; Corroded; Battery Problem

  END-USER ALLEGED THAT ON (B)(6) 2018 AROUND 0730 THE PARAMEDICS WERE CALLED DUE TO SYMPTOMS OF HYPOGLYCEMIA. END-USER ALLEGED THE METER WOULD NOT PROVIDE A RESULT AND WOULD DISPLAY THE LOW BATTERY ERROR CODE, E-B. IT IS UNKNOWN WHEN THE END-USER LAST RECEIVED A NUMERICAL RESULT ON THE PRODIGY METER. PARAMEDICS ARRIVED AND PERFORMED A BLOOD GLUCOSE TEST ON THE END-USER AND RECEIVED A 20 MG/DL WITH THEIR METER. END-USER WAS TREATED WITH IV FLUIDS (UNKNOWN CONCENTRATION OF FLUIDS) TO RAISE HIS BLOOD GLUCOSE. END-USER WAS TRANSPORTED TO THE HOSPITAL, UPON ARRIVAL END-USER ALLEGED HIS BLOOD GLUCOSE WAS 20 MG/DL AND HE RECEIVED MORE IV FLUIDS TO RAISE HIS BLOOD GLUCOSE LEVEL. END-USER REMAINED IN THE HOSPITAL FOR 5 DAYS AND NO OTHER TREATMENT WAS PROVIDED. UPON DISCHARGE THE END-USER'S BLOOD GLUCOSE WAS REPORTED TO BE 180 MG/DL. END-USER WAS ADVISED TO FOLLOW UP WITH PCP AND TO START A SLIDING SCALE WITH BASAGLAR. END-USER STATED HE DID NOT KNOW THE PRESCRIBED SLIDING SCALE. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

  Patient problems: Hypoglycemia

  MAUDE report 7548144 ↗
• InjuryApr 25, 2018Device Displays Incorrect Message

  END-USER ALLEGED THAT ON (B)(6) 2018 AROUND 0730 THE PARAMEDICS WERE CALLED DUE TO SYMPTOMS OF HYPOGLYCEMIA. END-USER ALLEGED THE METER WOULD NOT PROVIDE A RESULT AND WOULD DISPLAY THE LOW BATTERY ERROR CODE, E-B. IT IS UNKNOWN WHEN THE END-USER LAST RECEIVED A NUMERICAL RESULT ON THE PRODIGY METER. PARAMEDICS ARRIVED AND PERFORMED A BLOOD GLUCOSE TEST ON THE END-USER AND RECEIVED A 20 MG/DL WITH THEIR METER. END-USER WAS TREATED WITH IV FLUIDS (UNKNOWN CONCENTRATION OF FLUIDS) TO RAISE HIS BLOOD GLUCOSE. END-USER WAS TRANSPORTED TO THE HOSPITAL, UPON ARRIVAL END-USER ALLEGED HIS BLOOD GLUCOSE WAS 20MG/DL AND HE RECEIVED MORE IV FLUIDS TO RAISE HIS BLOOD GLUCOSE LEVEL. END-USER REMAINED IN THE HOSPITAL FOR 5 DAYS AND NO OTHER TREATMENT WAS PROVIDED. UPON DISCHARGE THE END-USER'S BLOOD GLUCOSE WAS REPORTED TO BE 180 MG/DL. END-USER WAS ADVISED TO FOLLOW UP WITH PCP AND TO START A SLIDING SCALE WITH BASAGLAR. END-USER STATED HE DID NOT KNOW THE PRESCRIBED SLIDING SCALE. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO TIS MEDICAL EVENT.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 7462747 ↗