Description of Event or Problem · 1
ON (B)(6) 2012, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT PRODUCTS (THE CHARGING CABLE AND AC ADAPTER) WERE MISSING FROM HIS ONETOUCH VERIO IQ KIT. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT REPORTEDLY DISCOVERED THE ALLEGED ISSUE TWO MONTHS PRIOR TO CONTACTING LFS. BEFORE DISCOVERING THE ALLEGED ISSUE THE PATIENT REPORTEDLY HAD EXPERIENCED SYMPTOMS OF FEVER, ACHING, NAUSEA, AND FAINTING (DATE/TIME UNSPECIFIED); IT IS NOT SPECIFIED WHAT METER THE PATIENT WAS TESTING WITH PRIOR TO AND AT THE ONSET OF HIS SYMPTOMS. THE PATIENT'S TESTING FREQUENCY IS NOT KNOWN AND OTHER THAN DIABETES, IT IS NOT CLEAR IF THE PATIENT SUFFERS FROM OTHER HEALTH CONDITIONS. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT MANAGES HIS DIABETES WITH INSULIN (NO ADJUSTMENTS). AFTER REALIZING THAT THE CHARGING CABLE AND AC ADAPTER WERE REPORTEDLY MISSING FROM HIS KIT, THE PATIENT CLAIMED HE CONTINUED WITH HIS USUAL DOSE OF MEDICATION; HOWEVER, IT IS NOT KNOWN IF THE PATIENT MONITORED HIS BLOOD GLUCOSE WITH ANOTHER/SECONDARY DEVICE AND IT IS NOT CLEAR WHY THE PATIENT DID NOT CONTACT LFS IMMEDIATELY AFTER NOTICING THE REPORTED ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, TWO WEEKS PRIOR TO CONTACTING LFS THE PATIENT REPORTEDLY WAS ADMINISTERED IV GLUCOSE BY A HEALTH CARE PROFESSIONAL (HCP) IN THE EMERGENCY ROOM (ER); THE REASON FOR THE PATIENT'S ER VISIT IS NOT KNOWN, IT IS NOT SPECIFIED WHAT THE PATIENT'S BLOOD GLUCOSE READING WAS PRIOR TO HIS ER VISIT AND WHICH METER THE PATIENT HAD OBTAINED THE READING WITH, AND IT IS ALSO NOT CLEAR WHEN THE PATIENT WAS RELEASED FROM THE ER. ON (B)(6) 2012 (BETWEEN 3-4PM) THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE READING OF '34MG/DL' WITH THE EMERGENCY MEDICAL SERVICE'S (EMS) METER AND WAS TRANSPORTED TO THE ER WHERE HE AGAIN WAS ADMINISTERED IV GLUCOSE AS TREATMENT; IT IS NOT KNOWN WHEN THE PATIENT WAS RELEASED FROM THE ER. DURING TROUBLESHOOTING, THE CSR NOTED THAT THE REPORTED PRODUCTS WERE MISSING FROM THE KIT. PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT HE OBTAINED A READING OF '34MG/DL' WITH THE EMS'S METER AND WAS TREATED BY AN HCP FOR SEVERE HYPOGLYCEMIA AFTER THE ALLEGED ISSUE WAS DISCOVERED.