Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HIS ONETOUCH VERIOPRO METER READ INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER CARE ADVOCATE (CCA) DURING A FOLLOW-UP CALL. THE PATIENT TESTS HIS BLOOD GLUCOSE 6X DAILY AND HIS RESULTS ARE USUALLY AROUND ¿100-170 MG/DL¿ (BEFORE MEALS). THE PATIENT MANAGES HIS DIABETES WITH NOVORAPID INSULIN (SLIDING SCALE) AND INSULATAR INSULIN (20 UNITS IN THE EVENING). IT IS NOT SPECIFIED WHEN THE ALLEGED ISSUE BEGAN; HOWEVER, THE PATIENT REPORTEDLY HAD BEEN TESTING WITH THE SUBJECT METER SINCE (B)(5) 2012. THE PATIENT COULD NOT SPECIFY BLOOD GLUCOSE RESULTS THAT WERE ¿HIGHER THAN USUAL¿ WHICH HE OBTAINED WITH THE SUBJECT METER WHEN THE ALLEGED ISSUE BEGAN. BASED ON THE REPORTED HIGHER RESULTS, HOWEVER, THE PATIENT ALLEGED HE MAY HAVE BEEN ¿OVERDOSING HIS INSULIN¿ (AMOUNT NOT SPECIFIED). AFTER, THE PATIENT CLAIMED HE FELT LOW BLOOD GLUCOSE SYMPTOMS OF SHAKING AND SWEATING. THE PATIENT ALLEGED THIS OCCURRED ON SEVERAL OCCASIONS BUT COULD NOT SPECIFY ALL THE DATES/ TIMES. IN (B)(6) 2012, THE PATIENT ALLEGED HE WAS IN A CAR ACCIDENT DUE TO THE REPORTED ISSUE. MORE RECENTLY, ON (B)(6) 2013, THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF ¿430 MG/DL¿ WITH THE SUBJECT METER BEFORE GOING TO BED. IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS USUAL MANAGEMENT ROUTINE AT THAT TIME. ON THE FOLLOWING DAY, THE PATIENT CLAIMED HE HAD SYMPTOMS OF CONVULSIONS AND ¿LOSS OF CONSCIOUSNESS.¿ THE PATIENT ALLEGED HE ALSO HAD A HEART ATTACK. EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED. THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿33 MG/DL¿ WITH THE EMS METER AND WAS TAKEN TO THE HOSPITAL. THE PATIENT ALLEGED HIS WIFE TRIED TO GIVE HIM (B)(6) AS TREATMENT. AT THE HOSPITAL, THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF ¿45 MG/DL¿ WITH THE HOSPITAL METER AND WAS ADMINISTERED FLUIDS (TYPE NOT SPECIFIED) FROM A ¿BAXTER BAG.¿ THE PATIENT WAS RELEASED FROM THE HOSPITAL AFTER 24 HOURS. ON AN UNSPECIFIED DATE/TIME, THE PATIENT REPORTEDLY ALSO COMPARED RESULTS OF THE SUBJECT METER WITH ANOTHER DEVICE. THE PATIENT OBTAINED A RESULT OF ¿250 MG/DL¿ WITH THE SUBJECT METER AND ¿130 MG/DL¿ WITH ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THE RESULTS FELL OUTSIDE OF EXPECTED VARIANCES FOR METER TO METER COMPARISONS. NO ADDITIONAL SYMPTOMS OR TREATMENT WAS SPECIFIED AT THAT TIME. THE PATIENT ALLEGED THAT THE CONTINUOUS USE OF THE SUBJECT METER HAS CAUSED HIM TO HAVE NEGATIVE IMPACTS ON HIS PHYSICAL, MENTAL AND SOCIAL STATE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. THE CCA EDUCATED THE PATIENT ON THE CORRECT TESTING PROCEDURE. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.