Prodigy AutoCode Blood Glucose Monitoring System 051885Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00384840518858), received between Apr 27, 2018 and Sep 11, 2019 — classified as 93 injuries.

The most frequently reported specific device problem is “High Test Results” (56 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.

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

  END USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 8PM AT THE END USER'S HOME. END USER STATED SHE FELL ASLEEP ON A CHAIR AND HER DAUGHTER ATTEMPTED TO WAKE HER AROUND 8:00PM. THE END USER WAS FEELING CONFUSED AND WAS NOT VERBALLY RESPONDING TO HER DAUGHTER. END-USER STATED THAT HER DAUGHTER GAVE HER 2 GLUCOSE TABLETS VIA MOUTH AND TESTED HER BLOOD GLUCOSE ON HER PRODIGY METER AND RECEIVED A RESULT OF 95 MG/DL. HER DAUGHTER CALLED PARAMEDICS ABOUT 10 MINUTES AFTER TESTING WITH HER PRODIGY METER. PARAMEDICS ARRIVED. APPROXIMATELY 15 MINUTES LATER AND TESTED THE END USER'S BLOOD GLUCOSE AND RECEIVED A RESULT OF 52 MG/DL. THE PARAMEDICS ADMINISTERED GLUCOSE THOUGH AN IV AND TRANSPORTED HER TO (B)(6) HOSPITAL. UPON ARRIVING AT THE HOSPITAL, THE END USER HAD A BLOOD GLUCOSE OF 138 MG/DL. THE DOCTORS GAVE THE CALLER SOME APPLE JUICE AND CHICKEN ON A ROLL. THE END USER WAS NOT ADMITTED TO THE HOSPITAL AND WAS DISCHARGED AFTER 4 HOURS WITH A BLOOD GLUCOSE OF 140 MG/DL.

  Patient problems: Confusion/ Disorientation; Hypoglycemia

  MAUDE report 8987598 ↗
• InjurySep 11, 2019High Test Results; High Test Results

  END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 5:00 PM AT HER HOME. END-USER STATED THAT HER PRODIGY METER GAVE HER A RESULT OF 291 MG/DL AND ABOUT 10 MINUTES AFTER THAT SHE STARTED TO FEEL DIZZY AND HER FINGERS GOT NUMB SO SHE CALLED THE PARAMEDICS. PARAMEDICS ARRIVED WITHIN 15 MINUTES AND TESTED WITH THEIR METER AND GOT A RESULT OF 115 MG/DL. PARAMEDICS DID NOT PROVIDE ANY TREATMENT FOR HER BLOOD GLUCOSE LEVEL; HOWEVER, THEY DID TRANSPORT HER TO THE HOSPITAL DUE TO HER BLOOD PRESSURE BEING HIGH. END-USER DOES NOT RECALL WHAT HER BLOOD GLUCOSE WAS UPON ARRIVING AT THE HOSPITAL. END-USER STATED THE HOSPITAL TESTED HER URINE AND BLOOD PRESSURE. SHE WAS TOLD SHE HAS A BLADDER INFECTION AND HER BLOOD PRESSURE IS HIGH, BUT SHE DOES NOT RECALL WHAT THE NUMBERS WERE. SHE WAS INSTRUCTED TO FOLLOW UP WITH HER PRIMARY DR. ENDUSER STATED THAT SHE WAS NOT ADMITTED SHE WAS DISCHARGED AFTER ABOUT 3 HOURS. THE END-USER WAS TREATED AT (B)(6) MEDICAL CENTER LOCATED AT (B)(6). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dizziness; Hypoglycemia; Numbness

  MAUDE report 8987596 ↗
• InjurySep 6, 2019High Test Results; High Test Results

  END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AT HIS HOME. END-USER STATED THAT HE WAS SEIZING IN HIS SLEEP AT AROUND 5 AM. HE STATED HIS WIFE FOUND HIM AND CALLED PARAMEDICS. END-USER HAD TESTED WITH HIS PRODIGY METER THE NIGHT BEFORE AT BED TIME (ABOUT 9 HOURS PRIOR) AND RECEIVED A RESULT OF 326MG/DL HE SAID HE THEN ADJUSTED HIS INSULIN PUMP. WHILE WAITING FOR THE PARAMEDICS TO ARRIVE HIS WIFE GAVE HIM APPLE JUICE. WHEN THE PARAMEDICS ARRIVED ABOUT 20-30 MINUTES LATER THEY TESTED HIS BLOOD GLUCOSE AND RECEIVED A RESULT OF 30MG/DL ON THEIR METER. PARAMEDICS DID NOT TEST WITH THE PRODIGY METER. HE WAS NOT TREATED BY THE PARAMEDICS FOR HIS LOW BLOOD SUGAR. HE WAS NOT TRANSPORTED TO THE HOSPITAL. WHEN PARAMEDICS LEFT HIS BLOOD GLUCOSE WAS 70MG/DL. END-USER STATED THAT THERE HAVE BEEN NO CHANGES TO HIS MEDICATION BUT THAT HE DID TURN HIS INSULIN PUMP DOWN TO PREVENT THE EVENT FROM REOCCURRING. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Hypoglycemia; Seizures

  MAUDE report 8968351 ↗
• InjurySep 6, 2019High Test Results; High Test Results

  THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2019-00040 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: Loss of consciousness; Seizures; Sweating

  MAUDE report 8968350 ↗
• InjurySep 5, 2019Low Test Results; Low Test Results

  CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 8PM AT THE END-USER'S HOME. CALLER STATED THAT THE END-USER TOOK A BLOOD GLUCOSE TEST AND RECEIVED A RESULT 50MG/DL. A NORMAL RESULT FOR THE END-USER FOR THAT TIME OF DAY IS 150-200MG/DL. PRIOR TO SEEKING MEDICAL ATTENTION, THE END-USER HAD DINNER AND TOOK HIS PRESCRIBED MEDICATIONS. CALLER STATED THAT THE END-USER APPEARED AWAKE BUT WAS NOT RESPONSIVE, SO SHE CALLED EMS. CALLER STATED THAT WHILE WAITING FOR THE ENS TO ARRIVE SHE TRIED TO GIVE THE END-USER CANDY, BUT HE WAS NOT RESPONDING. EMS ARRIVED 10-15 MINUTES AFTER TESTING WITH THE PRODIGY METER. THEY TESTED THE END-USER WITH THERE METER AND RECEIVED A RESULT OF 30MG/DL. THE END-USER WAS STILL UNRESPONSIVE, AND THE EMS ADMINISTERED A GLUCOSE IV. END-USER WAS THE TRANSPORTED TO (B)(6) HOSPITAL LOCATED AT (B)(6). CALLER WAS UNSURE OF WHAT HIS BLOOD GLUCOSE WAS UPON ARRIVING AT THE HOSPITAL. CALLER WAS UNABLE TO PROVIDE WHAT TREATMENT THE END-USER RECEIVED DUE TO NOT BE ALLOWED IN THE BACK ANT THE ER. SHE STATED THAT HE WAS NOT ADMITTED AND WAS THERE APPROXIMATELY 8 HOURS. CALLER WAS UNABLE TO RECALL WHAT THE END-USERS BLOOD GLUCOSE WAS WHEN HE WAS DISCHARGED

  Patient problems: Confusion/ Disorientation; Hypoglycemia

  MAUDE report 8963885 ↗
• InjurySep 5, 2019Low Test Results; Low Test Results

  CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 4:00PM AT THE END-USER'S HOME. CALLER STATED THAT HER HUSBAND WAS NOT RESPONDING TO HER VERBALLY, WAS CLENCHING HIS FIST AND BREATHING SHALLOWLY. CALLER STATED THAT SHE TESTED HIM WITH HIS PRODIGY METER AN RECEIVED A RESULT OF 21MG/DL. CALLER THEN CALLED THE PARAMEDICS. NO FOOD OR MEDICATION WAS CONSUMED WHILE WAITING FOR MEDICAL ATTENTION, BUT HE DID EAT HONEY NUT CHEERIOS AND TAKE 60 UNITS OF TUOJEO PRIOR TO NEEDING MEDICAL ATTENTION. PARAMEDICS ARRIVED AROUND 15 MINUTES LATER AND TESTED THE END-USER WITH THEIR METER AND RECEIVED A RESULT OF 50MG/DL. THE PARAMEDICS ADMINISTERED GLUCOSE IN AN IV AND TRANSPORTED THE END-USER TO THE HOSPITAL. CALLER IS UNABLE TO RECALL WHAT THE END-USERS BLOOD GLUCOSE WAS WHEN THEY ARRIVED AT THE HOSPITAL. THE END-USER DID NOT RECEIVE ANY TREATMENT FOR HIS BLOOD GLUCOSE WHILE AT THE HOSPITAL OTHER THAN THE GLUCOSE IV. THE END-USER HAD HIS MEDICATION CHANGED LANTUS TO TOUJEO 3 DAYS PRIOR TO SEEKING MEDICAL ATTENTION. THE END-USER WAS TOLD TO FOLLOW UP WITH HIS PRIMARY DR. HE WAS TREATED AT (B)(6).

  Patient problems: Hypoglycemia

  MAUDE report 8963884 ↗
• InjurySep 5, 2019Low Test Results; Low Test Results

  END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AT HER HOME. END-USER STATED THAT SHE RECEIVED A RESULT OF LO WHEN TESTING HER BLOOD SUGAR. END-USER THEN STATED THAT SHE TRIED TESTING WITH HER PRODIGY METER 10 TIMES AND CONTINUED TO GET A READING OF LO. SHE THEN TRIED TO RAISE HER BLOOD SUGAR BY EATING CAKE COOKIE AND JUICE. SHE THEN SAID SHE STARTED SWEATING AND HAD FEELINGS OF NERVOUSNESS. END-USER STATED SHE TOOK METFORMIN 1000MG/DL. SHE PROCEEDED TO DRIVE HERSELF TO THE EMERGENCY DEPARTMENT WHERE UPON ARRIVAL HER BLOOD GLUCOSE WAS 188MG/DL. SHE WAS NOT TREATED FOR HER BLOOD GLUCOSE DUE TO HER LEVEL BEING OK WHEN SHE ARRIVED AT THE HOSPITAL. SHE STATED THAT SHE WAS PRESCRIBED AMOXICILLIN 500MG/DL BUT DID NOT DISCLOSE WHY SHE WAS GIVEN THE ANTIBIOTIC. END-USER WAS TOLD TO FOLLOW UP WITH HER PRIMARY CARE DR. SHE WAS TREATED AT (B)(6) HOSPITAL LOCATED AT (B)(6) FOR 5 HOURS AND WAS NOT ADMITTED.

  Patient problems: Sweating

  MAUDE report 8963883 ↗
• InjuryAug 13, 2019Low Test Results; Low Test Results

  CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 4:00PM AT THE END-USER'S HOME. CALLER STATED THAT HER HUSBAND WAS NOT RESPONDING TO HER VERBALLY, WAS CLENCHING HIS FIST AND BREATHING SHALLOWLY. CALLER STATED THAT SHE TESTED HIM WITH HIS PRODIGY METER AN RECEIVED A RESULT OF 21MG/DL. CALLER THEN CALLED THE PARAMEDICS. NO FOOD OR MEDICATION WAS CONSUMED WHILE WAITING FOR MEDICAL ATTENTION, BUT HE DID EAT (B)(6) AND TAKE 60 UNITS OF TUOJEO PRIOR TO NEEDING MEDICAL ATTENTION. PARAMEDICS ARRIVED AROUND 15 MINUTES LATER AND TESTED THE END-USER WITH THEIR METER AND RECEIVED A RESULT OF 50MG/DL. THE PARAMEDICS ADMINISTERED GLUCOSE IN AN IV AND TRANSPORTED THE END-USER TO THE HOSPITAL. CALLER IS UNABLE TO RECALL WHAT THE END-USERS BLOOD GLUCOSE WAS WHEN THEY ARRIVED AT THE HOSPITAL. THE END-USER DID NOT RECEIVE ANY TREATMENT FOR HIS BLOOD GLUCOSE WHILE AT THE HOSPITAL OTHER THAN THE GLUCOSE IV. THE END-USER HAD HIS MEDICATION CHANGED FROM LANTUS TO TOUJEO 3 DAYS PRIOR TO SEEKING MEDICAL ATTENTION. THE END-USER WAS TOLD TO FOLLOW UP WITH HIS PRIMARY DR. HE WAS TREATED AT (B)(6) HEALTH SYSTEM LOCATED AT (B)(6).

  Patient problems: Hypoglycemia

  MAUDE report 8888999 ↗
• InjuryAug 13, 2019High Test Results; High Test Results

  END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 5:00PM AT HER HOME. END-USER STATED THAT HER PRODIGY METER GAVE HER A RESULT OF 291 MG/DL AND ABOUT 10 MINUTES AFTER THAT SHE STARTED TO FEEL DIZZY AND HER FINGERS GOT NUMB SO SHE CALLED THE PARAMEDICS. PARAMEDICS ARRIVED WITHIN 15 MINUTES AND TESTED WITH THEIR METER AND GOT A RESULT OF 115 MG/DL. PARAMEDICS DID NOT PROVIDE ANY TREATMENT FOR HER BLOOD GLUCOSE LEVEL; HOWEVER, THEY DID TRANSPORT HER TO THE HOSPITAL DUE TO HER BLOOD PRESSURE BEING HIGH. END-USER DOES NOT RECALL WHAT HER BLOOD GLUCOSE WAS UPON ARRIVING AT THE HOSPITAL. END-USER STATED THE HOSPITAL TESTED HER URINE AND BLOOD PRESSURE. SHE WAS TOLD SHE HAS A BLADDER INFECTION AND HER BLOOD PRESSURE IS HIGH, BUT SHE DOES NOT RECALL WHAT THE NUMBERS WERE. SHE WAS INSTRUCTED TO FOLLOW UP WITH HER PRIMARY DR. END-USER STATED THAT SHE WAS NOT ADMITTED SHE WAS DISCHARGED AFTER ABOUT 3 HOURS. THE END-USER WAS TREATED AT (B)(6) REGIONAL MEDICAL CENTER LOCATED AT (B)(6). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dizziness; Hypoglycemia; Numbness

  MAUDE report 8888746 ↗
• InjuryAug 12, 2019High Test Results; High Test Results

  REPORTER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON 7-20-2019 AROUND 12PM. END-USER WAS EATING AND STATED THEY NEEDED TO GO TO THE BATHROOM. END-USER TOOK GLIPIZIDE PRIOR TO DINNER, THEY FELL OVER IN THEIR CHAIR AND WAS TOO WEAK TO MOVE. REPORTER HELPED END-USER TO THE BATHROOM AND PERFORMED A BGT, METER READ 379MG/DL. CALLER PICKED UP THE END-USER AND BROUGHT THEM TO THEIR BED AND CALLED THE PARAMEDICS. PARAMEDICS ARRIVED ABOUT 25 MINUTES LATER, ENDUSER WAS RESPONSIVE BUT WAS CONFUSED. PARAMEDICS PERFORMED A BGT ON THEIR METER AND IT READ 25MG/DL AND THEN PERFORMED A BGT ON THE PRODIGY AND RECEIVED A RESULT OF 178MG/DL. PARAMEDICS GAVE THE END-USER GLUCOSE THROUGH AN IV. THE PARAMEDICS TRANSPORTED THE END-USER TO THE ER WHERE UPON ARRIVAL HER BLOOD GLUCOSE WAS 32MG/DL WHEN TESTED WITH THE HOSPITALS METER. SHE WAS THEN ADMITTED FOR 2 DAYS. CALLER DOES NOT REMEMBER WHAT OTHER BGT WERE PERFORMED OR THE DISCHARGE RESULT. THE DOCTOR TOOK THE END-USER OFF THE GLIPIZIDE AFTER MEDICAL ATTENTION WAS SOUGHT. A CAT SCAN WAS PERFORMED, AND THE RESULTS WERE NORMAL. SHE WAS TREATED AT (B)(6) MEDICAL CENTER EMERGENCY ROOM LOCATED AT (B)(6).

  Patient problems: Confusion/ Disorientation; Fainting; Hypoglycemia

  MAUDE report 8886285 ↗
• InjuryAug 12, 2019High Test Results; High Test Results

  CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON 07/09/2019 AT 12:00PM. HE STATED HE RECEIVED A RESULT OF 420 MG/DL, STARTED TO FEEL CONFUSED AND WENT TO AN URGENT CARE FACILITY. A NORMAL BLOOD GLUCOSE RESULT FOR HIM AT THAT TIME OF DAY IS 140-150 MG/DL. END-USER STATED THAT BEFORE GOING TO THE URGENT CARE HE TOOK 8 UNITS OF HUMALOG AND ATE 2 EGGS, 1 PIECE OF TOAST, AND 2 SAUSAGE PATTIES. UPON ARRIVING AT THE URGENT CARE, THEY CALLED PARAMEDICS AND HE WAS TRANSPORTED TO THE EMERGENCY ROOM. UPON ARRIVAL HIS BLOOD GLUCOSE WAS 22 MG/DL. END-USER STATED THEY CHECKED HIS BLOOD PRESSURE DID AN EKG AND BOTH WERE NORMAL. HE SAID HE RECEIVED A GLUCOSE SOLUTION BY MOUTH AT THE HOSPITAL. END-USER STATED HE WAS AT THE HOSPITAL ALMOST 3 HOURS BUT WAS NOT ADMITTED. HE IS REQUIRED TO TAKE 3 UNITS OF HUMALOG IF RESULT IS ABOVE 200. PRIOR TO DISCHARGE THE END-USER STATED HIS BLOOD GLUCOSE WAS 75 MG/DL. HE WAS TREATED AT (B)(6) HEALTH HOSPITAL LOCATED AT (B)(6). NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Confusion/ Disorientation; Hypoglycemia

  MAUDE report 8886284 ↗
• InjuryAug 12, 2019High Test Results; High Test Results

  END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 8PM AT THE END-USER'S HOME. END-USER STATED SHE FELL ASLEEP ON A CHAIR AND HER DAUGHTER ATTEMPTED TO WAKE HER AROUND 8:00PM. THE END-USER WAS FEELING CONFUSED AND WAS NOT VERBALLY RESPONDING TO HER DAUGHTER. END-USER STATED THAT HER DAUGHTER GAVE HER 2 GLUCOSE TABLETS VIA MOUTH AND TESTED HER BLOOD GLUCOSE ON HER PRODIGY METER AND RECEIVED A RESULT OF 95MG/DL. HER DAUGHTER CALLED PARAMEDICS ABOUT 10MINUTES AFTER TESTING WITH HER PRODIGY METER. PARAMEDICS ARRIVED APPROXIMATELY 15 MINUTES LATER AND TESTED THE END-USERS BLOOD GLUCOSE AND RECEIVED A RESULT OF 52MG/DL. THE PARAMEDICS ADMINISTERED GLUCOSE THOUGH AN IV AND TRANSPORTED HER TO (B)(6). UPON ARRIVING AT THE HOSPITAL, THE END-USER HAD A BLOOD GLUCOSE OF 138MG/DL. THE DOCTORS GAVE THE CALLER SOME APPLE JUICE AND CHICKEN ON A ROLL. THE END-USER WAS NOT ADMITTED TO THE HOSPITAL AND WAS DISCHARGED AFTER 4 HOURS WITH A BLOOD GLUCOSE OF 140MG/DL.

  Patient problems: Confusion/ Disorientation; Hypoglycemia

  MAUDE report 8883771 ↗
• InjuryAug 12, 2019Low Test Results; Low Test Results

  CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 8PM AT THE END-USER'S HOME. CALLER STATED THAT THE END-USER TOOK A BLOOD GLUCOSE TEST AND RECEIVED A RESULT 50MG/DL. A NORMAL RESULT FOR THE END-USER FOR THAT TIME OF DAY IS 150-200MG/DL. PRIOR TO SEEKING MEDICAL ATTENTION, THE END-USER HAD DINNER AND TOOK HIS PRESCRIBED MEDICATIONS. CALLER STATED THAT THE END-USER APPEARED AWAKE BUT WAS NOT RESPONSIVE, SO SHE CALLED EMS. CALLER STATED THAT WHILE WAITING FOR THE ENS TO ARRIVE SHE TRIED TO GIVE THE END-USER CANDY, BUT HE WAS NOT RESPONDING. EMS ARRIVED 10-15 MINUTES AFTER TESTING WITH THE PRODIGY METER. THEY TESTED THE END-USER WITH THERE METER AND RECEIVED A RESULT OF 30MG/DL. THE END-USER WAS STILL UNRESPONSIVE, AND THE EMS ADMINISTERED A GLUCOSE IV. END-USER WAS THE TRANSPORTED TO (B)(6). CALLER WAS UNSURE OF WHAT HIS BLOOD GLUCOSE WAS UPON ARRIVING AT THE HOSPITAL. CALLER WAS UNABLE TO PROVIDE WHAT TREATMENT THE END-USER RECEIVED DUE TO NOT BE ALLOWED IN THE BACK ANT THE ER. SHE STATED THAT HE WAS NOT ADMITTED AND WAS THERE APPROXIMATELY 8 HOURS. CALLER WAS UNABLE TO RECALL WHAT THE END-USERS BLOOD GLUCOSE WAS WHEN HE WAS DISCHARGED OR WHAT INSTRUCTIONS HE MAY

  Patient problems: Confusion/ Disorientation; Hypoglycemia

  MAUDE report 8883451 ↗
• InjuryAug 9, 2019High Test Results; High Test Results

  CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AT HIS HOME. CALLER REPORTED THAT THE METER IS READING HIGHER THAN NORMAL. CALLER STATED THE METER READ 96 MG/DL AND HE PASSED OUT AND STARTED TO HAVE A SEIZURE WITH COLD SWEATS 2 MINUTES LATER AND SHE PROCEEDED TO CALL 911. PARAMEDICS ARRIVED WITHIN 5 MINUTES AND THEIR METER READ 32 MG/DL. NO MEDICATION WAS GIVEN WHILE WAITING FOR PARAMEDICS DUE TO THE END-USER BEING SEIZING AND BEING UNRESPONSIVE. PARAMEDICS GAVE THE END-USER A GLUCOSE SOLUTION BY IV. END-USER WAS NOT TRANSPORTED TO THE HOSPITAL. PARAMEDICS ADVISED HIM TO EAT SOMETHING WHEN THEY LEFT. CALLER IS UNSURE OF WHAT HIS BLOOD GLUCOSE WAS WHEN THE PARAMEDICS LEFT.

  Patient problems: Loss of consciousness; Seizures; Sweating

  MAUDE report 8878415 ↗
• InjuryAug 8, 2019High Test Results; High Test Results

  END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AT HIS HOME. END-USER STATED THAT HE WAS SEIZING IN HIS SLEEP AT AROUND 5 AM. HE STATED HIS WIFE FOUND HIM AND CALLED PARAMEDICS. END-USER HAD TESTED WITH HIS PRODIGY METER THE NIGHT BEFORE AT BED TIME (ABOUT 9 HOURS PRIOR) AND RECEIVED A RESULT OF 326MG/DL HE SAID HE THEN ADJUSTED HIS INSULIN PUMP. WHILE WAITING FOR THE PARAMEDICS TO ARRIVE HIS WIFE GAVE HIM APPLE JUICE. WHEN THE PARAMEDICS ARRIVED ABOUT 20-30 MINUTES LATER THEY TESTED HIS BLOOD GLUCOSE AND RECEIVED A RESULT OF 30MG/DL ON THEIR METER. PARAMEDICS DID NOT TEST WITH THE PRODIGY METER. HE WAS NOT TREATED BY THE PARAMEDICS FOR HIS LOW BLOOD SUGAR. HE WAS NOT TRANSPORTED TO THE HOSPITAL. WHEN PARAMEDICS LEFT HIS BLOOD GLUCOSE WAS 70MG/DL. END-USER STATED THAT THERE HAVE BEEN NO CHANGES TO HIS MEDICATION BUT THAT HE DID TURN HIS INSULIN PUMP DOWN TO PREVENT THE EVENT FROM REOCCURRING. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Hypoglycemia; Seizures

  MAUDE report 8873908 ↗
• InjuryAug 7, 2019Low Test Results; Low Test Results

  END-USER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AT HER HOME. END-USER STATED THAT SHE RECEIVED A RESULT OF LO WHEN TESTING HER BLOOD SUGAR. END-USER THEN STATED THAT SHE TRIED TESTING WITH HER PRODIGY METER 10 TIMES AND CONTINUED TO GET A READING OF LO. SHE THEN TRIED TO RAISE HER BLOOD SUGAR BY EATING CAKE COOKIE AND JUICE. SHE THEN SAID SHE STARTED SWEATING AND HAD FEELINGS OF NERVOUSNESS. END-USER STATED SHE TOOK METFORMIN 1000MG/DL. SHE PROCEEDED TO DRIVE HERSELF TO THE EMERGENCY DEPARTMENT WHERE UPON ARRIVAL HER BLOOD GLUCOSE WAS 188MG/DL. SHE WAS NOT TREATED FOR HER BLOOD GLUCOSE DUE TO HER LEVEL BEING OK WHEN SHE ARRIVED AT THE HOSPITAL. SHE STATED THAT SHE WAS PRESCRIBED AMOXICILLIN 500MG/DL BUT DID NOT DISCLOSE WHY SHE WAS GIVEN THE ANTIBIOTIC. END-USER WAS TOLD TO FOLLOW UP WITH HER PRIMARY CARE DR. SHE WAS TREATED AT (B)(6) HOSPITAL LOCATED AT (B)(6) FOR 5 HOURS AND WAS NOT ADMITTED.

  Patient problems: Sweating

  MAUDE report 8870683 ↗
• InjuryAug 6, 2019High Test Results; High Test Results

  IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 11:00AM. END-USER STATED THAT HE TOOK A BLOOD GLUCOSE TEST AND RECEIVED A RESULT OF 293MG/DL, A NORMAL RESULT FOR THAT TIME OF DAY IS 125MG/DL. HE THEN STATED THAT HE STARTED TO FEEL SHAKY AND CONFUSED. END-USER STATED HE WENT TO THE HOSPITAL ON HIS OWN. THERE WAS NO FOOD DRINK OR MEDICATION TAKEN PRIOR TO GOING TO THE HOSPITAL. HE DOES NOT RECALL WHAT IS BLOOD GLUCOSE WAS WHEN HE ARRIVED. HE DID NOT RECEIVE TREATMENT FOR HIS BLOOD GLUCOSE LEVELS. DOCTORS IN THE EMERGENCY ROOM RAN A CAT SCAN AND BLOOD WORK AND EVERYTHING CAME BACK NORMAL. END-USER STATED HE WAS AT THE HOSPITAL FOR 5 HOURS AND WAS NOT ADMITTED. THE END-USERS SLIDING SCALE IS AS FOLLOWS: HUMALOG: (SLIDING SCALE): 100-199MG/DL 7 1/2 UNITS 200-299MG/DL 15 UNITS 300-399MG/DL 22 1/2 UNITS 400-499MG/DL 30 UNITS. END-USER DOES NOT RECALL WHAT HIS BLOOD GLUCOSE WAS WHEN HE WAS DISCHARGED FROM (B)(6) HOSPITAL LOCATED AT (B)(6). NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Confusion/ Disorientation; Shaking/Tremors

  MAUDE report 8863539 ↗
• InjuryAug 6, 2019High Test Results; High Test Results

  IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 8:30PM. THE CALLER STATED THAT THE END-USER RECEIVED A READING OF 66MG/DL. END-USER THEN TOOK HER INSULIN BASED OFF THE RESULT SHE RECEIVED WHICH LED TO THE END-USER BEING FOUND UNRESPONSIVE. PARAMEDICS WERE CALLED AROUND 10 MINUTES AFTER TESTING WITH HER PRODIGY METER. PARAMEDICS ARRIVED WITHIN 10-15MINUTES AND TESTED HER BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 34MG/DL. THERE WAS ABOUT 20 MINUTES BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDICS METER. THERE WAS NO FOOD DRINK OR MEDICATIONS TAKEN WHILE WAITING FOR THE PARAMEDICS. THE END-USER WAS GIVEN 2 GLUCOSE IV SOLUTIONS AND WAS NOT TRANSPORTED TO THE HOSPITAL. THE END-USER TAKES THE FOLLOWING INSULIN LANTUS 25 UNITS AT NOON, NOVOLOG 2-10 UNITS WHEN SHE EATS, NOVOLOG 20 UNITS WHEN RESULT IS OVER 400MG/DL. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Loss of consciousness

  MAUDE report 8863536 ↗
• InjuryAug 1, 2019High Test Results; High Test Results

  CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AT 12:00PM. HE STATED HE RECEIVED A RESULT OF 420MG/DL, STARTED TO FEEL CONFUSED AND WENT TO AN URGENT CARE FACILITY. A NORMAL BLOOD GLUCOSE RESULT FOR HIM AT THAT TIME OF DAY IS 140-150MG/DL. END-USER STATED THAT BEFORE GOING TO THE URGENT CARE HE TOOK 8 UNITS OF HUMALOG AND ATE 2 EGGS, 1 PIECE OF TOAST, AND 2 SAUSAGE PATTIES. UPON ARRIVING AT THE URGENT CARE, THEY CALLED PARAMEDICS AND HE WAS TRANSPORTED TO THE EMERGENCY ROOM. UPON ARRIVAL HIS BLOOD GLUCOSE WAS 22MG/DL. END-USER STATED THEY CHECKED HIS BLOOD PRESSURE DID AN EKG AND BOTH WERE NORMAL. HE SAID HE RECEIVED A GLUCOSE SOLUTION BY MOUTH AT THE HOSPITAL. END-USER STATED HE WAS AT THE HOSPITAL ALMOST 3 HOURS BUT WAS NOT ADMITTED. HE IS REQUIRED TO TAKE 3 UNITS OF HUMALOG IF RESULT IS ABOVE 200. PRIOR TO DISCHARGE THE END-USER STATED HIS BLOOD GLUCOSE WAS 75MG/DL. HE WAS TREATED AT (B)(6) HOSPITAL LOCATED AT (B)(6). NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Confusion/ Disorientation; Hypoglycemia

  MAUDE report 8850049 ↗
• InjuryJul 31, 2019High Test Results; High Test Results

  REPORTER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 12PM. END-USER WAS EATING AND STATED THEY NEEDED TO GO TO THE BATHROOM. END-USER TOOK GLIPIZIDE PRIOR TO DINNER, THEY FELL OVER IN THEIR CHAIR AND WAS TOO WEAK TO MOVE. REPORTER HELPED END-USER TO THE BATHROOM AND PERFORMED A BGT, METER READ 379MG/DL. CALLER PICKED UP THE END-USER AND BROUGHT THEM TO THEIR BED AND CALLED THE PARAMEDICS. PARAMEDICS ARRIVED ABOUT 25MINUTES LATER, END-USER WAS RESPONSIVE BUT WAS CONFUSED. PARAMEDICS PERFORMED A BGT ON THEIR METER AND IT READ 25MG/DL AND THEN PERFORMED A BGT ON THE PRODIGY AND RECEIVED A RESULT OF 178MG/DL. PARAMEDICS GAVE THE END-USER GLUCOSE THROUGH AN IV. THE PARAMEDICS TRANSPORTED THE END-USER TO THE ER WHERE UPON ARRIVAL HER BLOOD GLUCOSE WAS 32MG/DL WHEN TESTED WITH THE HOSPITALS METER. SHE WAS THEN ADMITTED FOR 2 DAYS. CALLER DOES NOT REMEMBER WHAT OTHER BGT WERE PERFORMED OR THE DISCHARGE RESULT. THE DOCTOR TOOK THE END-USER OFF THE GLIPIZIDE AFTER MEDICAL ATTENTION WAS SOUGHT. A CAT SCAN WAS PERFORMED, AND THE RESULTS WERE NORMAL. SHE WAS TREATED AT (B)(6) MEDICAL CENTER EMERGENCY ROOM LOCATED AT (B)(6).

  Patient problems: Confusion/ Disorientation; Fainting; Hypoglycemia

  MAUDE report 8848462 ↗
• InjuryJul 22, 2019High Test Results; High Test Results

  THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2019-00029 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: Hypoglycemia; Loss of consciousness; Sweating

  MAUDE report 8810528 ↗
• InjuryJul 22, 2019High Test Results; High Test Results

  THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2019-00030 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

  MAUDE report 8810523 ↗
• InjuryJul 11, 2019High Test Results; High Test Results

  IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 11:00AM. END-USER STATED THAT HE TOOK A BLOOD GLUCOSE TEST AND RECEIVED A RESULT OF 293MG/DL, A NORMAL RESULT FOR THAT TIME OF DAY IS 125MG/DL. HE THEN STATED THAT HE STARTED TO FEEL SHAKY AND CONFUSED. END-USER STATED HE WENT TO THE HOSPITAL ON HIS OWN. THERE WAS NO FOOD DRINK OR MEDICATION TAKEN PRIOR TO GOING TO THE HOSPITAL. HE DOES NOT RECALL WHAT IS BLOOD GLUCOSE WAS WHEN HE ARRIVED. HE DID NOT RECEIVE TREATMENT FOR HIS BLOOD GLUCOSE LEVELS. DOCTORS IN THE EMERGENCY ROOM RAN A CAT SCAN AND BLOOD WORK AND EVERYTHING CAME BACK NORMAL. END-USER STATED HE WAS AT THE HOSPITAL FOR 5 HOURS AND WAS NOT ADMITTED. THE END-USERS SLIDING SCALE IS AS FOLLOWS: HUMALOG: (SLIDING SCALE): 100-199MG/DL 7 1/2 UNITS 200-299MG/DL 15 UNITS 300-399MG/DL 22 1/2 UNITS 400-499MG/DL 30 UNITS. END-USER DOES NOT RECALL WHAT HIS BLOOD GLUCOSE WAS WHEN HE WAS DISCHARGED FROM (B)(6) HOSPITAL LOCATED AT (B)(6). NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Confusion/ Disorientation; Shaking/Tremors

  MAUDE report 8780859 ↗
• InjuryJul 11, 2019High Test Results; High Test Results

  IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AROUND 8:30PM. THE CALLER STATED THAT THE END-USER RECEIVED A READING OF 66MG/DL. END-USER THEN TOOK HER INSULIN BASED OFF THE RESULT SHE RECEIVED WHICH LED TO THE END-USER BEING FOUND UNRESPONSIVE. PARAMEDICS WERE CALLED AROUND 10 MINUTES AFTER TESTING WITH HER PRODIGY METER. PARAMEDICS ARRIVED WITHIN 10-15MINUTES AND TESTED HER BLOOD GLUCOSE WITH THEIR METER AND RECEIVED A RESULT OF 34MG/DL. THERE WAS ABOUT 20 MINUTES BETWEEN TESTING WITH THE PRODIGY METER AND THE PARAMEDICS METER. THERE WAS NO FOOD DRINK OR MEDICATIONS TAKEN WHILE WAITING FOR THE PARAMEDICS. THE END-USER WAS GIVEN 2 GLUCOSE IV SOLUTIONS AND WAS NOT TRANSPORTED TO THE HOSPITAL. THE END-USER TAKES THE FOLLOWING INSULIN LANTUS 25 UNITS AT NOON, NOVOLOG 2-10 UNITS WHEN SHE EATS, NOVOLOG 20 UNITS WHEN RESULT IS OVER 400MG/DL. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Hyperglycemia; Loss of consciousness

  MAUDE report 8780408 ↗
• InjuryJul 10, 2019High Test Results; High Test Results

  IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2019 AT THE END-USES HOME. THE END-USER STATED THAT SHE PERFORMED A BLOOD GLUCOSE TEST AROUND 10:00AM AND RECEIVED A RESULT THAT WAS 519MG/DL. A NORMAL BLOOD GLUCOSE READING FOR HER IS AROUND 120MG/DL. END -USER STATED SHE WASN'T FEELING WELL, AND SHE DROVE HERSELF TO (B)(6) HEALTH LOCATED AT (B)(6). END-USER STATED THAT SHE DOES NOT REMEMBER WHAT HER BLOOD GLUCOSE WAS WHEN SHE ARRIVED AT THE HOSPITAL JUST THAT IT WAS HIGHER THAN NORMAL . SHE STATED THAT SHE WAS GIVEN A TABLET TO LOWER HER BLOOD GLUCOSE. SHE WAS DISCHARGED AFTER 6 HOURS AND HER BLOOD GLUCOSE WAS AROUND 200MG/DL. METER MEMORY WAS DELETED SO THE END-USER WAS UNABLE TO PROVIDE TEST RESULTS. END-USER WAS INFORMED THAT HER TEST STRIPS ARE EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Fatigue; Shaking/Tremors

  MAUDE report 8774945 ↗