Description of Event or Problem · 1
IN 2002, A PATIENT WAS HOSPITALIZED ALLEGEDLY FOR "HYPERGLYCEMIA" AND SUBSEQUENTLY DIED. THE FAMILY MEMBER INFORMED THE LIFESCAN OFFICE OF THE EVENT ONE MONTH LATER AFTER LODGING A COMPLAINT WITH THE POLICE AGAINST THE WHOLESALER WHO SOLD THEM THE STRIPS THAT THEY PURCHASED FOR THE PATIENT. THE PACKAGE OF STRIPS REPORTEDLY WAS NOT SEALED. WHEN THE FAMILY MEMBER OBJECTED TO THE PACKAGING, THE WHOLESALER ALLEGEDLY REPLIED THAT [THE MANUFACTURER] NO LONGER SEALS ITS PRODUCTS. LIFESCAN STRIP PACKAGES SHOULD IN FACT BE SEALED. INFORMATION ON TREATMENT, CAUSE OF DEATH, PREVIOUS TEST RESULTS, THE SUBJECT METER AND STRIPS ARE IN THE POSSESSION OF THE POLICE AND ARE NOT SHARED WITH LIFESCAN REPRESENTATIVES. PER THE FAMILY MEMBER, THE CUSTOMER'S RESULTS WITH THESE STRIPS SHOWED THAT THEIR BLOOD GLUCOSE WAS UNDER CONTROL. (THE EXACT RESULTS ARE UNAVAILABLE.) AFTER TESTING WITH THE STRIPS FOR A FEW DAYS, PATIENT BECAME SLEEPY AND BEGAN VOMITING. WITH THEIR METER RESULTS IN THE 50 AND 60 MG/DL RANGE DURING THESE SYMPTOMS, THE FAMILY FED PATIENT SUGAR. AT SOME POINT PATIENT WAS "RUSHED" TO THE HOSPITAL WHERE THEIR BLOOD GLUCOSE WAS ABOVE 490 MG/DL UPON ADMISSION AND AFTER A REPEAT TEST. IT IS UNKNOWN IF THE TESTS WERE WITH HOSPITAL'S METER OR LABORATORY INSTRUMENT. PATIENT HAS EXPIRED. SINCE FAMILY MEMBER BOUGHT THIS PACK, PATIENT SAID THAT THEY HAD FINALLY CONTROLLED THEIR SUGAR." OTHER FAMILY MEMBERS TESTED WITH THE METER AND STRIPS [TO CHECK THE METER], OBTAINING "VERY LOW" RESULTS AND "WRONG RESULTS" AS COMPARED TO THE LAB AND THE DOCTOR'S METERS. NO DETAILS REGARDING THESE ALLEGED COMPARISONS ARE KNOWN. THE POLICE AND FAMILY MEMBER BROUGHT THE PRODUCTS TO LIFESCAN OFFICE ON AUGUST 15, 2002 WHERE THEY ASKED IF THE METER WAS IN WORKING CONDITION. THEY DID NOT MENTION ANY INFORMATION ABOUT THE PRODUCT OR THE INCIDENT. THEY ALLOWED LIFESCAN REPRESENTATIVE TO TEST THE METER WITH THE OFFICE QUALITY CONTROL MATERIAL; THE METER PASSED THE THREE TESTS PERFORMED. THEY WOULD NOT ALLOW A CONTROL SOLUTION TEST ON THE SUBJECT STRIPS, STATING "THAT WOULD BE USING UP EVIDENCE". THEY SHOWED A NOTE, INSTEAD, BY A PHYSICIAN WHO HAD TESTED THE STRIPS WITH FAMILY MEMBER OWN METER, FINDING THE STRIPS TO BE "LOOKING EXPIRED AND THE RESULTS ERRATIC AND "DANGEROUSLY LOW". ON SEPTEMBER 11, THE POLICE RETURNED TO ALLOW THE LIFESCAN REPRESENTATIVE TO TEST THE STRIPS AND METER WITH CONTROL SOLUTION. REPRESENTATIVE INDICATED THE TEST SPOT ON THE STRIPS APPEARED PALE AND PALLID [NOT THE EXPECTED WHITE COLOR] COMPARED WITH FRESHLY OPENED STRIPS. THE RESULTS WITH CONTROL WERE 148, 146, AND 148 MG/DL, ABOVE THE CONTROL SOLUTION RANGE OF 93-125 MG/DL. IT IS UNKNOWN HOW THE PATIENT STORED THEIR STRIPS. ANOTHER TEST WITH THE METER'S CHECK STRIP REPORTEDLY WAS AGAIN IN RANGE. IT IS NOT CLEAR IF THE TEST STRIPS USED BY THE CUSTOMER ARE COUNTERFEIT, BUT THE LIFESCAN OFFICE STATED THEY DO NOT SELL PRODUCTS TO THE PARTICULAR WHOLESALER. THE PATIENT RECEIVED BLOOD GLUCOSE READING OF 490 MG/DL IN THE HOSPITAL. WHETHER PATIENT HAD ANY OTHER HEALTH CONDITIONS IS UNREVEALED. DESPITE INSUFFICIENT EVIDENCE TO CONCLUDE THAT LIFESCAN PRODUCTS CONTRIBUTED TO THE PATIENT'S DEMISE, THIS CASE IS REPORTED SINCE IT INVOLVES THE DEATH OF A CUSTOMER.