DARIO BLOOD GLUCOSE MONITORING SYSTEM
Report
- Report Number
- 3010606081-2023-00067
- Event Type
- Malfunction
- Date Received
- November 9, 2023
- Date of Event
- October 10, 2023
- Report Date
- November 9, 2023
- Manufacturer
- LABSTYLE INNOVATIONS LTD.
- Product Code
- NBW
- PMA / PMN Number
- K150817
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
DURING TROUBLESHOOTING ON THE PHONE WITH DARIO'S REPRESENTATIVE, IT WAS DETERMINED THAT THE USER WAS USING A CARTRIDGE OF STRIPS THAT HAD EXPIRED. DARIO'S USER GUIDE STATES IN THE SECTION FACTORS THAT MAY LEAD TO INACCURATE RESULTS: "THE TEST STRIP IS EXPIRED." AND IN THE TEST STRIP PRECAUTIONS SECTION: "CHECK THE "USE BY" DATE ON THE TEST STRIP CARTRIDGE. DO NOT USE THE TEST STRIPS AFTER THAT DATE". IN ADDITION, IT WAS DETERMINED THAT THE USER WAS TRANSFERRING NEW DARIO STRIPS INTO THE OLD DARIO STRIPS CARTRIDGE. DARIO'S USER GUIDE STATES IN THE SECTION STORAGE AND HANDLING: "DO NOT TRANSFER TEST STRIPS FROM ONE CARTRIDGE TO ANOTHER" A REPLACEMENT OF DARIO'S STRIPS AND CONTROL SOLUTION WAS SENT TO THE USER TO MAKE SURE THAT THE DARIO STRIPS ARE READING CORRECTLY. AFTER THE NEW DARIO STRIPS AND CONTROL SOLUTION WERE RECEIVED, DARIO'S REPRESENTATIVE FOLLOWED UP WITH THE USER TO PERFORM THE CONTROL SOLUTION TEST. THE USER'S DARIO METER WAS TESTED WITH CONTROL SOLUTION AND A NEW CARTRIDGE OF STRIPS: THE METER READ WITHIN RANGE FOR BOTH TESTS. CONTROL SOLUTION LEVEL 1 TEST RESULTS WAS 154 MG/DL (RANGE 107-155 MG/DL); CONTROL SOLUTION LEVEL 2 TEST RESULTS WAS 221 MG/DL (RANGE 183-264 MG/DL). ALTHOUGH THE CONTROL SOLUTION TEST WAS READING WITHIN RANGE, THE USER REPORTED THAT HIS BG READING WITH THE NEW STRIPS CARTRIDGE WAS 75 MG/DL, COMPARED TO A BG READING OF 91 MG/DL WITH HIS NON-DARIO METER, AND A BG READING OF 90 MG/DL FROM THE DOCTOR'S OFFICE. THE USER ALSO REPORTED THAT WITH THE NEW CARTRIDGE OF STRIPS, HE IS ALWAYS RECEIVING A FASTING BG READING BELOW 80 MG/DL. DUE TO THESE LOW READINGS, A REPLACEMENT OF DARIO'S METER, WAS SENT TO THE USER TOGETHER WITH A RETURN MATERIAL AUTHORIZATION (RMA) PACKAGE, TO FURTHER INVESTIGATE THIS ISSUE. AS OF THIS DATE, THE RMA WAS NOT RECEIVED. IF THE RMA IS RECEIVED AT A LATER DATE, A FOLLOW UP REPORT WILL BE SUBMITTED. THERE IS NOT ENOUGH INFORMATION AVAILABLE REGARDING THE DARIO METER AND STRIPS TO INVESTIGATE. NO RESOLUTION IS AVAILABLE. ADDITION FOR THE FOLLOW-UP REPORT: RMA INVESTIGATION TEST RESULTS WITH DARIO'S CONTROL SOLUTION CONCLUDED THAT THE READINGS WERE WITHIN RANGE: LEVEL 1 TEST RESULTS WERE 134 MG/DL, 143 MG/DL, 144 MG/DL, WITHIN THE RANGE OF 107-155 MG/DL. LEVEL 2 TEST RESULTS WERE 225 MG/DL, 226 MG/DL, 232 MG/DL, WITHIN THE RANGE OF 183-264 MG/DL. THE RMA PACKAGE WAS RECEIVED FOR INVESTIGATION ON NOVEMBER 9TH, 2023. THE METER WAS TESTED, AND WAS READING WITHIN RANGE. THEREFORE, IT WAS DETERMINED THAT THIS COMPLAINT IS NOT DUE TO A METER ISSUE. THERE IS NOT ENOUGH INFORMATION REGARDING THE DARIO STRIPS TO INVESTIGATE. NO RESOLUTION IS AVAILABLE.
DURING TROUBLESHOOTING ON THE PHONE WITH DARIO'S REPRESENTATIVE, IT WAS DETERMINED THAT THE USER WAS USING A CARTRIDGE OF STRIPS THAT HAD EXPIRED. DARIO'S USER GUIDE STATES IN THE SECTION FACTORS THAT MAY LEAD TO INACCURATE RESULTS: "THE TEST STRIP IS EXPIRED." AND IN THE TEST STRIP PRECAUTIONS SECTION: "CHECK THE "USE BY" DATE ON THE TEST STRIP CARTRIDGE. DO NOT USE THE TEST STRIPS AFTER THAT DATE" IN ADDITION, IT WAS DETERMINED THAT THE USER WAS TRANSFERRING NEW DARIO STRIPS INTO THE OLD DARIO STRIPS CARTRIDGE. DARIO'S USER GUIDE STATES IN THE SECTION STORAGE AND HANDLING: "DO NOT TRANSFER TEST STRIPS FROM ONE CARTRIDGE TO ANOTHER" A REPLACEMENT OF DARIO'S STRIPS AND CONTROL SOLUTION WAS SENT TO THE USER TO MAKE SURE THAT THE DARIO STRIPS ARE READING CORRECTLY. AFTER THE NEW DARIO STRIPS AND CONTROL SOLUTION WERE RECEIVED, DARIO'S REPRESENTATIVE FOLLOWED UP WITH THE USER TO PERFORM THE CONTROL SOLUTION TEST. THE USER'S DARIO METER WAS TESTED WITH CONTROL SOLUTION AND A NEW CARTRIDGE OF STRIPS: THE METER READ WITHIN RANGE FOR BOTH TESTS. CONTROL SOLUTION LEVEL 1 TEST RESULTS WAS 154 MG/DL (RANGE 107-155 MG/DL) CONTROL SOLUTION LEVEL 2 TEST RESULTS WAS 221 MG/DL (RANGE 183-264 MG/DL) ALTHOUGH THE CONTROL SOLUTION TEST WAS READING WITHIN RANGE, THE USER REPORTED THAT HIS BG READING WITH THE NEW STRIPS CARTRIDGE WAS 75 MG/DL, COMPARED TO A BG READING OF 91 MG/DL WITH HIS NON-DARIO METER, AND A BG READING OF 90 MG/DL FROM THE DOCTOR'S OFFICE. THE USER ALSO REPORTED THAT WITH THE NEW CARTRIDGE OF STRIPS, HE IS ALWAYS RECEIVING A FASTING BG READING BELOW 80 MG/DL. DUE TO THESE LOW READINGS, A REPLACEMENT OF DARIO'S METER, WAS SENT TO THE USER TOGETHER WITH A RETURN MATERIAL AUTHORIZATION (RMA) PACKAGE, TO FURTHER INVESTIGATE THIS ISSUE. AS OF THIS DATE, THE RMA WAS NOT RECEIVED. IF THE RMA IS RECEIVED AT A LATER DATE, A FOLLOW UP REPORT WILL BE SUBMITTED. THERE IS NOT ENOUGH INFORMATION AVAILABLE REGARDING THE DARIO METER AND STRIPS TO INVESTIGATE. NO RESOLUTION IS AVAILABLE.
ON OCTOBER 10TH, 2023, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT PRIOR TO CONTACTING DARIO, HE HAD BEEN RECEIVING HIGH BG READINGS FOR SEVERAL MONTHS WHEN COMPARED TO HIS NON-DARIO METER. HOWEVER, THE USER ALSO REPORTED THAT DURING A ROUTINE DOCTOR'S VISIT, HE RECEIVED BG READINGS THAT WERE LOWER THAN THE BG READINGS THAT HE WAS RECEIVING FROM HIS DARIO METER, WHICH IS IN CONTRAST TO HIS INITIAL HIGH READINGS.
ON OCTOBER 10TH, 2023, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE (BG) READINGS. THE USER REPORTED THAT PRIOR TO CONTACTING DARIO, HE HAD BEEN RECEIVING HIGH BG READINGS FOR SEVERAL MONTHS WHEN COMPARED TO HIS NON-DARIO METER. HOWEVER, THE USER ALSO REPORTED THAT DURING A ROUTINE DOCTOR'S VISIT, HE RECEIVED BG READINGS THAT WERE LOWER THAN THE BG READINGS THAT HE WAS RECEIVING FROM HIS DARIO METER, WHICH IS IN CONTRAST TO HIS INITIAL HIGH READINGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1804469 | DARIO BLOOD GLUCOSE MONITORING SYSTEM | GLUCOMETER | NBW | LABSTYLE INNOVATIONS LTD. | 2104301 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |