Gmate® Origin Blood Glucose Monitoring System PG-310Recalls & reported problems
PHILOSYS Co., Ltd · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08809301160077), received between Sep 24, 2019 and Sep 27, 2019 — classified as 4 malfunctions.
The most frequently reported specific device problem is “High Test Results” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- High Test Results2
- Incorrect, Inadequate or Imprecise Result or Readings2
Patient problems
- No Known Impact Or Consequence To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2019Incorrect, Inadequate or Imprecise Result or Readings
BLOOD GLUCOSE READING RESULTS IS HIGHER ABOUT 20~30 MG/DL WHEN COMPARING WITH OTHER GLUCOSE METER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9127123 ↗MalfunctionSep 27, 2019Incorrect, Inadequate or Imprecise Result or Readings
WHEN BLOOD GLUCOSE VALUES WERE SIMULTANEOUSLY MEASURED USING GMATE VOICE AND GMATE ORIGIN, THE DIFFERENCE IN BLOOD GLUCOSE READINGS BETWEEN THE TWO DEVICES WAS MORE THAN 40 MG/DL. (THE RESULT OF GMATE ORIGIN IS MEASURED HIGHER.)
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9127122 ↗MalfunctionSep 24, 2019High Test Results
BLOOD GLUCOSE LEVELS ARE MEASURED TOO HIGH. CUSTOMER CHECKED THE HIGH ALARM THAT APPEARS WHEN THE SCREEN IS ABOVE 600 MG/DL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9108048 ↗MalfunctionSep 24, 2019High Test Results
HE IS TAKING MEDICINE AS A DIABETIC PATIENT, AND WHEN HE MEASURED HIS BLOOD GLUCOSE ON AN EMPTY STOMACH USING GMATE ORIGIN, HE FOUND AN AVERAGE OF 30MG/DL HIGHER THAN ANY OTHER PRODUCT, AND CONFIRMATION OF THE MEASUREMENT DEVIATION WAS REQUESTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9108016 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.