Accu-Chek Aviva 08340331001Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00365702702394), received between Jul 27, 2023 and Jul 27, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K133862); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE BLOOD GLUCOSE MONITOR WAS UNAVAILABLE FOR USE DUE TO AN ERROR MESSAGE. ON THE MORNING OF (B)(6) 2023 THE CUSTOMER RECEIVED A BLOOD GLUCOSE RESULT OF 153 MG/DL AT 7:30AM. THIS WAS A NORMAL BLOOD GLUCOSE READING FOR THE CUSTOMER AND HE ADMINISTERED HIS NORMAL 20 UNITS OF LANTUS. SOMETIME BETWEEN THE TIMEFRAME OF 12:30 PM AND 5:15 PM THE CUSTOMER LOSE COCONSCIOUSNESS AND HAD A SEIZURE DUE TO LOW BLOOD SUGAR. THE CUSTOMER WAS HOME ALONE WHEN HE LOST CONSCIOUSNESS AND COULD NOT RECALL THE EXACT TIME. THE CUSTOMER ATTEMPTED TO TEST HIS BLOOD SUGAR PRIOR TO LOSING CONSCIOUSNESS AND RECEIVED AN E6 ERROR MESSAGE ON THE DEVICE. THE CUSTOMER'S WIFE ARRIVED HOME AT 5:15PM AND DISCOVERED THE CUSTOMER CONSCIOUS IN THE BATHROOM, SHE ATTEMPTED TO TEST HIS BLOOD GLUCOSE AND AGAIN RECEIVED AN ERROR MESSAGE OF E6. THE WIFE THEN TREATED THE CUSTOMER WITH ORANGE JUICE AND PEANUT BUTTER. AT 5:30PM THE WIFE ATTEMPTED TO TEST THE CUSTOMER'S BLOOD GLUCOSE AGAIN, AND FINALLY RECEIVED A RESULT OF 109 MG/DL. THE WIFE DROVE THE CUSTOMER TO THE HOSPITAL. THEY ARRIVED AT THE HOSPITAL AT 6:15P AND THE HOSPITAL TESTED THE CUSTOMER'S BLOOD GLUCOSE AND RECEIVED A RESULT OF 240 MG/DL. THE H

  Patient problems: Hypoglycemia

  MAUDE report 17410298 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K133862. One submission often covers many models, so check the product and lot details in each record.

• Z-2766-2019 · Jun 12, 2017 · Terminated
  Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar)
• Z-2765-2019 · Jun 12, 2017 · Terminated
  Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek Aviva Plus Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in