GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM
Report
- Report Number
- 9616936-2025-00003
- Event Type
- Injury
- Date Received
- March 14, 2025
- Date of Event
- February 14, 2025
- Report Date
- April 16, 2025
- Manufacturer
- APEX BIOTECHNOLOGY CORP.
- Product Code
- NBW
- UDI-DI
- 00015482570101
- PMA / PMN Number
- K113098
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INFORMATION PROVIDED BY IMPORTER (ARKRAY FACTORY USA, INC.): THE METER AND STRIPS INVOLVED IN THE INCIDENT WERE RETURNED ON 07 MARCH 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 2025-09-13. BLOOD AND CONTROL SOLUTION PASSED TESTING WITH NO FAILURES DETECTED. THE METER WILL BE FORWARDED TO THE MANUFACTURER. MANUFACTURER NARRATIVE (APEX BIOTECHNOLOGY CORP.): AS THE TEST RESULTS FROM IMPORTER (ARKRAY), THERE ARE NO PROBLEMS WITH THE COMPLAINED METER. THE METER WAS NOT RETURNED BY IMPORTER (ARKRAY) AND THE COMPLAINED METER WAS NOT EVALUATED BY MANUFACTURER (APEX).
INFORMATION PROVIDED BY IMPORTER (ARKRAY FACTORY USA, INC.): 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. MANUFACTURER NARRATIVE (APEX BIOTECHNOLOGY CORP.): 1. IN-HOUSE VENOUS BLOOD TEST FOR THE RETAINED METER AND THE SAME LOT OF RETAINED TEST STRIPS IS CONDUCTED. THE RESULTS ARE PASSED WITH SPECIFIED SPECIFICATION. PLEASE REFER TO "25000025-S8 VENOUS BLOOD TEST RESULTS-RETAIN." 2. ROOT CAUSE OR POSSIBLE REASON FOR THIS COMPLAINT HAS NOT BEEN IDENTIFIED. 3. IF THE COMPLAINED METER OR STRIPS RETURNED FROM THE USER THROUGH THE IMPORTER, INVESTIGATION WILL BE INITIATED AND A FOLLOW-UP MDR WILL BE SUBMITTED.
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 8:31AM 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.
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 8:31AM 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2144144 | GLUCOCARD EXPRESSION BLOOD GLUCOSE SYSTEM | GLUCOCARD EXPRESSION | NBW | APEX BIOTECHNOLOGY CORP. | 571100 | B4S2404006 | 00015482570101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Female | Life Threatening| H| R |