GLUCOCARD EXPRESSION BLOOD GLUCOCSE TEST STRIPS

Additional Manufacturer Narrative

INFORMATION PROVIDED BY IMPORTER (B)(6): QS LAB TESTING WAS PERFORMED. CUSTOMER RETURNED 24 STRIPS OF THE SPECIFIED LOT. RETURNED STRIPS WERE TESTED WITH QS METER AND RETAIN CONTROL SOLUTION LOT TAC230906M, EXPIRATION 2025-09-12. CONTROL SOLUTION FAILED TESTING CONFIRMING THE COMPLAINT. RETAIN STRIPS OF SPECIFIED LOT WERE TESTED WITH SAME RETAIN CONTROL SOLUTION AND QS METER AND CONTROL SOLUTION PASSED TESTING. BLOOD TESTING WAS ALSO PERFORMED WITH RETURNED STRIPS AND A QS METER AND HIGH BLOOD READINGS WERE RECEIVED. RETAIN STRIPS OF SPECIFIED LOT WERE THEN TESTED WITH QS METER WITH BLOOD AND PASSED TESTING. THIS INDICATES FAILURE IS A STRIP ISSUE. DESICCANT TESTING WAS PERFORMED ON THE RETURNED STRIP BOTTLE AND PASSED TESTING WHICH INDICATES THAT THE FAILURES ARE NOT RELATED TO EXHAUSTED DESICCANT. STRIPS WILL BE FORWARDED TO THE MANUFACTURER FOR FURTHER INVESTIGATION. MANUFACTURER NARRATIVE: 1. IN-HOUSE CLINICAL CAPILLARY BLOOD TEST (FINGER TIP BLOOD TEST) FOR RETAIN METER, RETURNED TEST STRIP AND RETAIN SAMPLE OF TEST STRIP LOT B4S2312002 ARE CONDUCED. THE RESULTS OF RETURNED TEST STRIP ARE FAILED AND THE RESULTS OF RETAINED TEST STRIP ARE PASSED WITH SPECIFIED SPECIFICATIONS. PLEASE REFER TO THE ATTACHMENT "25000015-S8 FINGER TIP TEST RESULT". 2. DRYING TEST OF DESICCANTS IN BOTTLE CAP ARE CONDUCTED. THE RESULTS SHOWED THAT THE MOISTURE OF RETURNED STRIP BOTTLE ARE MUCH HIGHER THAN THAT OF RETAINED STRIP BOTTLE. THE DESICCANT IN THE RETURNED STRIP BOTTLE BECAME HUMID, WHICH MAY LEAD TO ABNORMAL READINGS OF THE TEST STRIPS. PLEASE REFER TO ATTACHMENT "25000015-S8 DRYING TEST OF DESICCANTS".

Description of Event or Problem

CUSTOMER REPORTED ISSUES OF HIGH CONTROL SOLUTION READINGS. COMPLAINT WAS REVIEWED FOR INVESTIGATION AND REPORTABILITY ON DECEMBER 6, 2024. COMPLAINT WAS MARKED FOR INVESTIGATION AND DETERMINED NOT REPORTABLE PER ARKRAY'S PER INTERNAL PROCEDURES.ON JANUARY 28, 2025, THE RETURNED STRIPS FAILED TESTING BY GENERATING HIGH RESULTS OUT OF SPECIFICATION. THE STRIPS GAVE HIGH READINGS, MAKING THIS COMPLAINT REPORTABLE TO THE MANUFACTURER AS A MALFUNCTION. JANUARY 28, 2025 MARKS THE AWARE DATE OF MDR FILING.