GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM

Additional Manufacturer Narrative

THE METER AND STRIPS INVOLVED IN THE INCIDENT WERE NOT RETURNED FOR INVESTIGATION. THE RETAIN STRIPS OF THE SPECIFIED LOT WERE TESTED WITH A QS METER AND PASSED TESTING WITH NO FAILURES DETECTED. IF THE CUSTOMER RETURNS ANY COMPLAINT PRODUCTS, THE PRODUCTS WILL BE TESTED AND A FOLLOW-UP MDR WILL BE FILED.

Description of Event or Problem

CUSTOMER STATES SHE IS RECEIVING LOW READINGS ON HER TWO EXPRESSION METERS, AND SHE WENT TO THE ER AS A RESULT. CUSTOMER STATES HER CONTROL SOLUTION WAS OPENED IN (B)(6) 2024, BUT DID A TEST AND THOUGHT IT WAS OUT OF RANGE WITH A READING OF 105 AND THE RANGE WAS 90-122. ADVISED CUSTOMER THAT CONTROL SOLUTION IS GOOD FOR THREE MONTHS ONCE OPENED. THE CUSTOMER IS UNSURE HOW LONG SHE HAS HAD THE METERS. SHE STATES WE SENT HER ONE OF THEM AND THE OTHER SHE PURCHASED FROM HER LOCAL STORE. CUSTOMER STATES SHE USED BOTH METERS TODAY AND RECEIVED READINGS OF 62 AT 8:31 AM WHICH CONCERNED HER AND PROMPTED HER TO GO TO THE HOSPITAL AROUND 8:49 AM. SHE USED TWO DIFFERENT SAMPLES ON TWO DIFFERENT HANDS USING A NEW LANCET. WHEN SHE WENT TO THE HOSPITAL, THEY TESTED HER AND RECEIVED A READING OF 105, AND AFTER EATING FOOD, THE READING WAS 189. THEY DISCHARGED HER AFTER MONITORING HER GLUCOSE AFTER EATING FOOD. WHEN SHE ARRIVED HOME, BOTH OF HER EXPRESSION METERS GAVE HER A RESULT OF 102, WHICH SHE STILL FEELS IS TOO LOW. CUSTOMER STATES SHE HAS HAD VERY CONTROLLED DIABETES FOR YEARS, BUT WITH THE LOW READINGS ON BOTH METERS AND THE WAY SHE WAS FEELING, SHE WENT TO THE HOSPITAL. CUSTOMER STORES METER AND STRIPS IN HER BEDROOM. CUSTOMER WASHES AND DRIES HANDS BEFORE TESTING. CUSTOMER USES A NEW LANCET. REPLACED BOTH METERS AND TEST STRIPS FOR HER. EXPLAINED THE RETURN PROCESS AND MAILED RETURN LABEL.

Additional Manufacturer Narrative

THE METER AND STRIPS INVOLVED IN THE COMPLAINT WERE RETURNED ON 3/7/2025. THE RETURNED METER WAS TESTED WITH BOTH RETURNED STRIPS AND RETAIN STRIPS OF THE SPECIFIED LOT WITH BOTH BLOOD AND RETAIN CONTROL SOLUTION, LOT TAC230907M, EXPIRATION (B)(6) 2025. BLOOD AND CONTROL SOLUTION PASSED TESTING WITH NO FAILURES DETECTED. THE METER WILL BE FORWARDED TO THE MANUFACTURER.