Description of Event or Problem · 1
ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH AND ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE¿S (CCA) DOCUMENTATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2014, AT AN UNKNOWN TIME. SHE REPORTED TESTING ON THE SUBJECT METER AND OBTAINING READINGS OF ¿438, 300, 293, 247, 209, 236, 234, 215, 220, 228 MG/DL¿ PERFORMED AT UNSPECIFIED TIMES. THE PATIENT FELT THE READINGS WERE HIGHER THAN HER USUAL READINGS. IT IS NOT KNOWN WHAT THE PATIENT CONSIDERS TO BE NORMAL. IN ADDITION TO THIS COMPARISON, THE PATIENT ALSO REPORTED ERRATIC RESULTS OF ¿213MG/DL AND 246MG/DL ON THE SAME DAY, HOWEVER, THE BLOOD SAMPLE WAS NOT TAKEN FROM THE SAME SITE. THE PATIENT MANAGES HER DIABETES WITH AN UNKNOWN TYPE OF ORAL MEDICATIONS. THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF ¿SWEATING, SHAKING AND TIREDNESS.¿ IMMEDIATELY AFTER TESTING BUT DESPITE HER SYMPTOMS, SHE DENIED RECEIVING ANY FORM OF MEDICAL INTERVENTION. THE PATIENT REPORTED THAT SHE DECREASED HER FOOD/DRINK CONSUMPTION ON (B)(6) 2014. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE TEST STRIPS WERE NOT EXPIRED AND STORED CORRECTLY. A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATE HIGH READINGS ON THE SUBJECT METER, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.