Description of Event or Problem · 1
ON (B)(6) 2018, THE REPORTER CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT HIS WIFE¿S ONETOUCH ULTRA 2 METER READ INACCURATELY HIGH COMPARED TO HER FEELINGS AND/OR NORMAL READINGS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE REPORTER STATED THAT THE METER ISSUE FIRST BEGAN ON THE EVENING OF (B)(6) 2017, ALLEGING THAT HIS WIFE OBTAINED INACCURATE HIGH BLOOD GLUCOSE READINGS OF ¿191, 162, 167 AND 188 MG/DL¿ WITH THE SUBJECT METER. METER TO FEELINGS/NORMAL RESULTS COMPARISONS DO NOT MEET THE CRITERIA NECESSARY FOR LFS TO DETERMINE AN INACCURACY. THE REPORTER STATED THAT HIS WIFE MANAGES HER DIABETES USING INSULIN (SELF-ADJUSTER), AND IN RESPONSE TO THE ALLEGED INACCURATE READINGS, SHE INJECTED HER NORMAL DOSE OF INSULIN (LANTUS 30 UNITS). AT 6.30 PM THE REPORTER ALLEGES THAT THE PATIENT DEVELOPED SYMPTOMS OF ¿PALPITATIONS AND WEAKNESS¿. IN RESPONSE TO THE SYMPTOMS THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM. THE REPORTER WAS UNABLE TO CONFIRM WHAT TREATMENT THE PATIENT RECEIVED, BUT STATED ¿THE DOCTOR SAID HIS WIFE HAD A LOW BLOOD SUGAR AND SHE RECEIVED TREATMENT AND MEDICATION¿. THE PATIENT WAS IN HOSPITAL FROM 7 PM ON (B)(6) 2017 UNTIL 6PM ON (B)(6) 2018. DURING TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE, AND THAT THE PATIENT¿S TEST STRIPS HAD BEEN STORED CORRECTLY, WERE WITHIN EXPIRY DATE. THE CSR NOTED THE PATIENT DID NOT HAVE CONTROL SOLUTION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS AND POSSIBLY RECEIVED TREATMENT FOR A SERIOUS INJURY ADVERSE EVENT AFTER THE ALLEGED PRODUCT ISSUE BEGAN.