On Call Express Blood Glucose Monitoring System G115-10DRecalls & reported problems
Acon Laboratories, Inc. · Blood Glucose Monitoring System includes Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G) · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00682607557158), received between Jun 21, 2018 and Jun 21, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).
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
Device problems
- Device Operates Differently Than Expected1
- Low Readings1
Patient problems
- Hyperglycemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2018Low Readings; Device Operates Differently Than Expected; Low Readings; Device Operates Differently Than Expected
CUSTOMER REPORTED HIS METER IS READING LOW. HE HAD BEEN TESTING AND GETTING NORMAL BLOOD SUGARS BUT ON SATURDAY ((B)(6) 2018) HE WAS SYMPTOMATIC OF HIGH BLOOD SUGARS (SWEATING, FELT SHAKY) SO HE WENT TO THE HOSPITAL. AT THE HOSPITAL HIS BLOOD SUGAR WAS OVER 500 MG/DL. THEY TREATED HIM FOR HIGH BG AND HE WAS RELEASED ON THURSDAY. HE BOUGHT A CONTOUR NEXT METER AND HE TESTED HIS OCX METER AGAINST THE CONTOUR (OCX=24 MG/DL AND THE CONTOUR=165 MG/DL). HE TRIED TESTING THE OCX CONTROL BUT HE COULD NOT GET A READING. HIS STRIPS HAVE BEEN OPEN 1 DAY. CUSTOMER WAS HOSPITALIZED ON SATURDAY, TREATED FOR HIGH BLOOD SUGAR, AND RELEASED ON THURSDAY.
Patient problems: Hyperglycemia
MAUDE report 7627371 ↗
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- ARCHITECT 7K62-25Abbott Ireland · SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED)94 reports
- ARCHITECT 08K2812Abbott GmbH · Single (specified) analyte controls (assayed and unassayed)1 recall12 reports
- CONTOUR® NEXT 9697Ascensia Diabetes Care US Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)56 reports
- McKesson 5011Mckesson Medical-Surgical Inc. · Single (Specified) Analyte Controls (Assayed And Unassayed)1 recall0 reports
- HCG SERUM CONTROL KIT 138Sekisui Diagnostics, LLC · Single (specified) analyte controls (assayed and unassayed)1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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