Accu-Chek Compact Plus 05599415160Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00075537474198), received between Dec 18, 2019 and Feb 26, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (10 reports).

1 other recall cover devices cleared under the same FDA submission (K113614); 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 335 MG/DL (SYSTEM 1) AND 123 MG/DL (SYSTEM 2).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11388030 ↗
• MalfunctionNov 23, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 407 MG/DL (ACCU-CHEK GUIDE ME METER) AND 139 MG/DL (ACCU-CHEK COMPACT PLUS METER).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10886982 ↗
• MalfunctionOct 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 200 MG/DL AND 95 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10676363 ↗
• MalfunctionMay 7, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 198 MG/DL (SYSTEM 1), 27 MG/DL (SYSTEM 1), AND 131 MG/DL (SYSTEM 2).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10032844 ↗
• MalfunctionMay 7, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 198 MG/DL (SYSTEM 1), 27 MG/DL (SYSTEM 1), AND 131 MG/DL (SYSTEM 2).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10032780 ↗
• MalfunctionApr 3, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 300 MG/DL (PATIENT METER) AND 120 MG/DL (PROFESSIONAL METER).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9920932 ↗
• MalfunctionApr 1, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 461 MG/DL AND 82 MG/DL (SYSTEM 1) AND 83 MG/DL (SYSTEM 2).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9910119 ↗
• MalfunctionFeb 21, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 40 MG/DL AND 240 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9741004 ↗
• MalfunctionDec 23, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 180 MG/DL AND 95 MG/DL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9511858 ↗
• MalfunctionDec 18, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 10 MINUTES: 148 MG/DL (AVIVA) AND 300 MG/DL (COMPACT).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9489278 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113614. One submission often covers many models, so check the product and lot details in each record.

• Z-1616-2014 · Apr 14, 2014 · Terminated
  ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count