GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM

Description of Event or Problem

FRIEND RAQUEL IS CALLING IN FOR CUSTOMER. RJ038296. CUSTOMER HAS HAD THE METER FOR APPROXIMATELY TWO YEARS SHE THINKS. LOT B4S2201010 - 2023-10-11 - 50CT. CUSTOMER IS RECEIVING HIGHER READINGS. YESTERDAY THE CUSTOMER CALLED HER FRIEND BECAUSE SHE WAS NOT FEELING WELL. FRIEND RAQUEL'S METER READ 64 AND ROSA'S METER READ 280 IN A COMPARISON TEST. RAQUEL HAS NOVA MAX PLUS METER. THE FOLLOWING IS FROM THE HISTORY OF THE TWO METERS. PLEASE NOTE THE DATE IS INCORRECT ON ROSA'S METER AND THE CALLER IS UNSURE IF THE TIME IS SET CORRECTLY: CUSTOMER'S METER - 8/28 - 5:36 - 280 WAS THE READING RECEIVED AND CUSTOMER CALLED HER FRIEND TO LET HER KNOW SHE WAS NOT FEELING WELL. CALLER'S METER - 4/26 - 64 WAS THE READING RECEIVED AFTER SHE GOT TO HER HOUSE AROUND THE SAME TIME. CALLER GAVE CUSTOMER JUICE AT THIS TIME. CALLER'S METER - 4/26 - 1:22 PM - 143. THE FOLLOWING READINGS ARE THE READINGS RECEIVED ON THE CUSTOMER'S METER THAT CUSTOMER IS CLAIMING ARE TOO HIGH BEFORE THE INSTANCE OF THE COMPARISON READINGS ABOVE: 8/24 - 18:05 - 336, 8/24 - 18:08 - 208, 8/24 - 18:08 - 288, 8/24 - 18:09 - 274. RAQUEL STATES THAT THE READINGS FROM 8/24 WERE NOT DONE WITH THE SAME BLOOD SAMPLE, BUT MAY HAVE BEEN DONE ON DIFFERENT HANDS. RAQUEL IS GOING TO GO OVER AND CHECK ROSA'S BLOOD GLUCOSE WITH HER METER EACH DAY UNTIL REPLACEMENT IS RECEIVED. REPLACED METER, STRIPS AND SENT RETURN LABEL.

Additional Manufacturer Narrative

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