Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT WAS CONTACTED BY THE MEDICAL SURVEILLANCE SPECIALIST (MSS) FOR A FOLLOW UP CALL REGARDING A DATE/TIME ISSUE. DURING THE FOLLOW UP CALL THE PATIENT CLAIMED HER ONETOUCH VERIOIQ METER WAS READING INACCURATELY HIGH WHICH ALLEGEDLY LED TO AN INJURY. THE COMPLAINT WAS CLASSIFIED BASED ON THE INFORMATION COLLECTED BY THE MSS. THE PATIENT CLAIMED THE ALLEGED INACCURACY ISSUE BEGAN SOMETIME IN (B)(6) 2013. THE PATIENT CLAIMED SHE TESTED WITH THE SUBJECT METER AND RECEIVED READINGS THAT SHE CONSIDERED ¿NORMAL¿ WHEN HER BLOOD GLUCOSE WAS ACTUALLY LOW. THE PATIENT COULD NOT RECALL WHAT THE EXACT READINGS WERE AND WAS UNABLE TO RECALL MANY DETAILS. THE PATIENT TESTS 3-4 TIMES PER DAY AND MANAGES HER DIABETES WITH MEAL TIME ¿R¿ INSULIN 5 UNITS AT BREAKFAST AND LUNCH AND SELF ADJUSTS BASED ON HER METER READINGS AND 40 UNITS OF LANTUS INSULIN AT BEDTIME. SHE CLAIMED THAT SHE CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. SHE CLAIMED ON AN UNKNOWN DATE/TIME TESTED AT BREAKFAST AND STATED HER BLOOD GLUCOSE WAS HIGHER THAN USUAL (UNKNOWN READING). SHE TOOK HER 5 UNITS OF INSULIN, ATE BREAKFAST AND WENT OUT. SHE TESTED AT LUNCH AND GOT A NORMAL READING, ATE HER LUNCH AND TOOK ANOTHER 5 UNITS OF INSULIN AND CAME BACK HOME BETWEEN 3-4PM. SHE STATED SHE WAS FEELING TIRED SO SHE DRANK SOME SODA AND TOOK A NAP. SHE COULD NOT RECALL IF SHE TESTED AT THE TIME. SHE WOKE UP APPROXIMATELY 1 HOUR LATER AND WAS ¿SWEATING AND FELT DIZZY.¿ SHE CONTACTED HER NEIGHBOR WHO CALLED THE PARAMEDICS ON BEHALF OF THE PATIENT. WHEN THE EMERGENCY MEDICAL SERVICE (EMS) ARRIVED THEY TESTED THE PATIENT USING AN EMS METER AND SHE CLAIMED THE READING ON THEIR DEVICE WAS ¿10 MG/DL.¿ THE EMS TREATED THE PATIENT WITH 5 TUBES OF GLUCOSE GEL, GAVE HER SODA AND JELLY AT AN UNSPECIFIED TIME. SHE REPORTED THAT SHE REFUSED TO GO TO THE HOSPITAL SO THE EMS STAYED WITH HER UNTIL HER SYMPTOMS ABATED. THE PATIENT DID NOT HAVE HER METER OR TEST STRIPS AVAILABLE FOR TROUBLESHOOTING. SHE REPORTED THAT UNIT OF MEASURE WAS CORRECT AND THE TEST STRIPS WERE UNEXPIRED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND SUBJECT PRODUCTS WERE REQUESTED TO BE RETURNED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED ¿NORMAL READINGS¿ ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA THAT REQUIRED TREATMENT FROM A HEALTH CARE PROFESSIONAL AFTER THE ALLEGED METER ISSUE BEGAN.