Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT'S RELATIVE CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE REPORTER AND/OR PATIENT COULD NOT BE REACHED BY PHONE TO OBTAIN ADDITIONAL INFORMATION. THE PATIENT'S RELATIVE REPORTED THAT THE ALLEGED METER INACCURACY BEGAN APPROXIMATELY 1 MONTH PRIOR TO CONTACTING LFS. THE REPORTER CLAIMED THAT THE PATIENT OBTAINED A MESSAGE OF "HI" WITH THE SUBJECT METER. PER THE OWNER'S BOOKLET, THIS MESSAGE APPEARS WHEN THE METER DETECTS A BLOOD GLUCOSE READING GREATER THAN 600 MG/DL. THE REPORTER INFORMED THE CCA THAT THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF INSULIN AND ORAL MEDICATION. IT IS NOT KNOWN, WHAT ACTION, IF ANY, THE PATIENT TOOK IN RESPONSE TO THE MESSAGE OF "HI". THE REPORTER CLAIMED THAT 1 HOUR AFTER THE ALLEGED METER INACCURACY STARTED THE PATIENT DEVELOPED SYMPTOMS OF "SHAKY". IT IS NOT KNOWN IF THE PATIENT ASSOCIATED THE SYMPTOM WITH A LOW BLOOD GLUCOSE EXCURSION. AT THE TIME OF THE CALL, THE PATIENT'S RELATIVE MENTIONED THAT ON THE LAST WEEK OF JANUARY THE PATIENT WAS TAKEN TO THE ER AND WAS TREATED WITH INSULIN. THE REPORTER DID NOT KNOW IF THE PATIENT'S BLOOD GLUCOSE WAS TESTED WITH ANOTHER DEVICE. NO ADDITIONAL INFORMATION REGARDING REASON FOR ER VISIT WAS PROVIDED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE REPORTER DID NOT HAVE CONTROL SOLUTION AVAILABLE AT THE TIME OF THE CALL TO TEST THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER OBTAINING AN ALLEGED INACCURATE HIGH READING/MESSAGE WITH THE SUBJECT METER.