POGO Automatic Blood Glucose Monitoring System 00856176008001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00856176008001), received between Mar 30, 2021 and Jul 27, 2022 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE USER CALLED CUSTOMER SUPPORT TO REPORT THAT HER BLOOD GLUCOSE LEVEL WAS 40 MG/DL ON THE LEFT HAND. SHE HAD TESTED AGAIN ON THE OTHER HAND AND WAS FOUND TO BE 46 MG/DL ON THE RIGHT HAND. CUSTOMER SUPPORT INDICATED THAT THE VALUE IS EXTREMELY LOW. UPON CUSTOMER SUPPORT INQUIRING WITH THE USER, SHE INDICATED THAT SHE FELT SLIGHTLY LIGHTHEADED. CUSTOMER SUPPORT SUGGESTED CALLING THE DOCTOR. SHE REQUESTED CONTROL SOLUTIONS AND WERE SENT TO THEM. THE USER INDICATED THAT THEY WOULD GO TO URGENT CARE TO GET CHECKED OUT. ON (B)(6) 2022, CUSTOMER SUPPORT RETURNED THE USER'S VOICEMAIL THAT SHE HAD SPOKEN THE OTHER DAY AND WAS TOLD TO GO TO AN URGENT CARE BECAUSE HER POGO READINGS WERE 40 AND 46 MG/DL. WHEN SHE WENT TO THE URGENT CARE, HER RESULTS AT THE URGENT CARE WERE 111 MG/DL AND POGO READ 79 MG/DL. CUSTOMER SUPPORT EXPLAINED TO THE USER THAT HER METER WILL BE REPLACED AND IF SHE COULD SEND THE METER AND CARTRIDGES BACK IN THE RMA KIT SENT TO HER. SHE STATED THAT SHE HAD NOT RECEIVED THE CONTROL SOLUTIONS YET. SHE WAS TOLD THAT SHE CAN USE THE CONTROL SOLUTIONS WHEN SHE RECEIVES THE NEW METER. SHE HAD NO FURTHER QUESTIONS. ON (B)(6) 2022, CUSTOMER SUPPORT REQUESTED STA

  Patient problems: Hypoglycemia

  MAUDE report 15118169 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE CUSTOMER REPORTED DIFFICULTIES GETTING ENOUGH BLOOD TO TEST. CUSTOMER SUPPORT (CS) PROVIDED TECHNIQUES TO STIMULATE BLOOD FLOW SUCH AS RUNNING WARM WATER OVER FINGERS AND MILKING BLOOD TO FINGERTIPS. THE CUSTOMER REQUESTED CONTROL SOLUTION TO VERIFY THAT THE METER AND CARTRIDGE WERE WORKING WELL TOGETHER. CS SENT TWO REPLACEMENT CARTRIDGES AND AN RMA KIT FOR THE RETURN OF TWO CARTRIDGES FOR INVESTIGATION. ON (B)(6) 2021, THE CUSTOMER REPORTED THAT THE CONTROL SOLUTION TEST PASSED WHICH INDICATES THAT THE METER AND CARTRIDGE WERE WORKING AS INTENDED DESPITE CUSTOMER STATING HER RESULTS DID NOT MATCH HOW SHE FELT. SHE ALSO REPORTED A PREVIOUS READING OF 38 MG/DL THE PRIOR WEEKEND. THE CUSTOMER STATED THAT ON (B)(6) 2021, SHE TESTED USING HER NORMAL TECHNIQUE OF WARMING HER HANDS WITH WARM WATER AND THEN MILKING HER FINGERS USING VASELINE. SHE ADVISED THAT ON THAT NIGHT HER BLOOD GLUCOSE READING WAS LOWER THAN 100 MG/DL BUT SHE FELT LIKE IT WAS OVER 100 MG/DL SO SHE TOOK 500 MG OF METFORMIN BEFORE BED. AT THIS TIME HER PRESCRIPTION WAS FOR 500 MG OF METFORMIN UP TO 2 TIMES A DAY IF BLOOD GLUCOSE READINGS ARE OVER 100 MG/DL. WHEN SHE WOKE UP ON (B)(6) 2021 SHE FELT

  Patient problems: Hypoglycemia

  MAUDE report 11587091 ↗