ACCU-CHEK INFORM II 05942861001Recalls & reported problems

Summary

The FDA's MAUDE database contains 354 adverse event reports that list this exact device (DI 00365702428102), received between Jul 13, 2018 and Sep 23, 2026 — classified as 2 deaths, 4 injuries, 348 malfunctions.

The most frequently reported specific device problem is “High Test Results” (126 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. 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 25 most recent of 354 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50870602 ↗
• MalfunctionSep 23, 2026Non Reproducible Results

  An allegation of questionable blood glucose results was received for a single patient tested consecutively on an Accu-Chek Inform II meter + RF meter. Testing performed within 15 minutes yielded 323 mg/dL and 145 mg/dL. The lower result was deemed correct.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865753 ↗
• MalfunctionSep 22, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859945 ↗
• MalfunctionAug 19, 2026Non Reproducible Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50327395 ↗
• MalfunctionApr 20, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS FROM THE ACCUCHEK INFORM II METER. AT 11:57 A.M., THE METER RESULT WAS 206 MG/DL. AT 11:58 A.M., THE METER RESULT WAS 144 MG/DL. AT 11:59 A.M., THE METER RESULT WAS 117 MG/DL. THE INITIAL RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24932055 ↗
• MalfunctionApr 2, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS FOR TWO PATIENTS TESTED WITH ACCU-CHEK INFORM II METER SERIAL NUMBER: (B)(6). PATIENT 1: ON (B)(6) 2026, AT 10:18, THE METER RESULT WAS 521 MG/DL. AT 10:20, THE METER RESULT WAS 285 MG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT. AT 10:21, THE METER RESULT WAS 277 MG/DL. PATIENT 2: ON (B)(6) 2026, AT 23:32, THE METER RESULT WAS "HI" (REPRESENTED AS 601 MG/DL). AT 23:34, THE METER RESULT WAS 149 MG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT. ON (B)(6) 2026, AT 4:32, THE LABORATORY RESULT WAS 117 MG/DL. THE CUSTOMER DID NOT KNOW IF DIFFERENT FINGERS WERE USED TO COLLECT SAMPLES FOR EACH TEST. THE CUSTOMER HAS A POLICY OF REPEATING TESTING IF THE METER RESULT IS > 400 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764372 ↗
• MalfunctionApr 1, 2026Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT GLUCOSE RESULTS FOR 1 PATIENT TESTED ON AN ACCU-CHEK INFORM II METER. THE INITIAL RESULT FROM THE METER WAS 383 MG/DL. THE PATIENT WAS RETESTED WITHIN 15 MINUTES, AND THE RESULT WAS 61 MG/DL. THE RESULT OF 61 MG/DL WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757831 ↗
• MalfunctionMar 30, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT GLUCOSE RESULTS FOR ONE PATIENT TESTED WITH ACCU-CHEK INFORM II METER SERIAL NUMBER (B)(6). A SAMPLE FROM THE PATIENT WAS TESTED USING THE METER, RESULTING IN A GLUCOSE VALUE OF 90 MG/DL. THE FACILITY HAS A POLICY TO REPEAT TESTING IF THE OPERATOR DOES NOT BELIEVE THE RESULT OR IF THE RESULT IS > 400 MG/DL. METER TESTING WAS REPEATED ON THE PATIENT TWICE, RESULTING IN GLUCOSE VALUES OF 450 MG/DL AND 469 MG/DL. ALL MEASUREMENTS WERE PERFORMED WITHIN 15 MINUTES. THE CUSTOMER DEEMED THE REPEAT VALUE OF 450 MG/DL TO BE CORRECT AND THE PATIENT WAS TREATED BASED ON THIS RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24731169 ↗
• MalfunctionMar 30, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT GLUCOSE RESULTS FOR TWO PATIENTS TESTED WITH ACCU-CHEK INFORM II METER SERIAL NUMBER (B)(6). THE CUSTOMER HAS A POLICY OF REPEATING TESTING IF THE METER RESULT IS > 400 MG/DL. A SAMPLE FROM THE FIRST PATIENT WAS TESTED USING THE METER, RESULTING IN A GLUCOSE VALUE OF "HI" (> 600 MG/DL). THE TEST WAS REPEATED ON THE PATIENT USING THE METER, RESULTING IN A VALUE OF 218 MG/DL. ANOTHER MEASUREMENT OF THE PATIENT WAS PERFORMED USING THE PATIENT'S DEXCOM CONTINUOUS GLUCOSE MONITOR AND THE RESULT WAS 216 MG/DL. ALL MEASUREMENTS WERE PERFORMED WITHIN 15 MINUTES. THE SECOND RESULT OF 218 MG/DL WAS BELIEVED TO BE CORRECT AND THE PATIENT WAS TREATED BASED ON THAT RESULT. THE CUSTOMER DID NOT KNOW IF DIFFERENT FINGERS WERE USED TO COLLECT SAMPLES FOR EACH TEST. A SAMPLE FROM THE SECOND PATIENT WAS TESTED USING THE METER, RESULTING IN A GLUCOSE VALUE OF 461 MG/DL. TESTING WAS REPEATED ON THE PATIENT AND THE METER RESULT WAS 253 MG/DL. ALL MEASUREMENTS WERE PERFORMED WITHIN 15 MINUTES. THE SECOND RESULT OF 253 MG/DL WAS BELIEVED TO BE CORRECT AND THE PATIENT WAS TREATED BASED ON THAT RESULT. THE CUSTOMER DID NOT KNOW IF DIFFERENT FINGERS WERE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24731163 ↗
• MalfunctionMar 30, 2026Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT GLUCOSE RESULTS FOR 1 PATIENT TESTED ON AN ACCU-CHEK INFORM II METER. THE RESULT AT 12:26 P.M. WAS 442 MG/DL. THE RESULT AT 12:29 P.M. WAS 171 MG/DL. THE RESULT AT 12:31 P.M. WAS 173 MG/DL. THE PATIENT WAS ASYMPTOMATIC. THE RESULTS OF 171 MG/DL AND 173 MG/DL WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716470 ↗
• MalfunctionMar 30, 2026Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF A DISCREPANT HIGH GLUCOSE RESULT FOR 1 PATIENT TESTED ON AN ACCU-CHEK INFORM II METER. THE RESULT AT 12:12 P.M. WAS HI (RESULT > 600 MG/DL). THE RESULT AT 12:14 P.M. WAS 226 MG/DL. THE PATIENT WAS ASYMPTOMATIC. THE RESULT OF 226 MG/DL WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716146 ↗
• MalfunctionMar 19, 2026Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF A QUESTIONABLE GLUCOSE RESULT FROM ONE PATIENT TESTED WITH TWO ACCU-CHEK INFORM II METER + RF METERS (METER 1 AND METER 2). AT 8:44 AM, METER 1'S RESULT WAS 513 MG/DL. AT 8:57 AM, METER 2'S RESULT WAS 187 MG/DL. METER 2'S RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641215 ↗
• MalfunctionMar 13, 2026Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM TWO ACCU-CHEK INFORM II METERS WITH SERIAL NUMBERS (B)(6). AT 5:16 A.M., METER (B)(6) GAVE A RESULT OF 224 MG/DL. AT 5:20 A.M., METER (B)(6) GAVE A RESULT OF 124 MG/DL. AT 4:11 P.M., METER (B)(6) GAVE A RESULT OF >600 MG/DL. AT 4:20 P.M., METER (B)(6) GAVE A RESULT OF 274 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598360 ↗
• MalfunctionMar 6, 2026High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT TESTED ON AN ACCU-CHEK INFORM II METER + RF COMPARED TO THE LABORATORY. AT 7:48 A.M., THE RESULT FROM THE METER FROM A FINGER STICK WAS > 600 MG/DL. AT 7:50 A.M., THE RESULT FROM THE METER USING A DIFFERENT FINGER STICK WAS > 600 MG/DL. A SAMPLE WAS DRAWN FOR THE LABORATORY AT 8:03 A.M. WITH A RESULT OF 83 MG/DL. THE RESULT FROM THE LABORATORY WAS BELIEVED TO BE CORRECT. THE PATIENT WAS ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24529585 ↗
• MalfunctionFeb 18, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS AND ERROR MESSAGES USING THE ACCU-CHEK INFORM II TEST STRIPS WITH THE ACCU-CHEK INFORM II METER + RF. RESULTS WERE PROVIDED FOR ONE INDIVIDUAL. THE CUSTOMER TESTED THEMSELVES TO TRY TO RECREATE THE ISSUE. THE INITIAL RESULT AT 18:55 WAS 152 MG/DL. THE SECOND RESULT AT 18:56 WAS 111 MG/DL. THE SAME FINGER AND FINGERSTICK FROM THE FIRST RESULT WERE USED FOR THE SECOND RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376240 ↗
• MalfunctionJan 29, 2026Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE GLUCOSE RESULT USING THE ACCU-CHEK INFORM II TEST STRIPS FROM TWO ACCU-CHEK INFORM II METERS + RF FOR ONE PATIENT. THE INITIAL RESULT FROM METER A AT 12:58 WAS 67 MG/DL. THE SECOND RESULT FROM METER A AT 12:59 WAS 60 MG/DL. THE THIRD RESULT FROM METER A AT 14:01 WAS 27 MG/DL. THE FOURTH RESULT FROM METER A AT 14:03 WAS "LO", STATING THAT THE RESULT WAS LESS THAN 20 MG/DL. A RESULT FROM METER B AT 14:09 WAS 108 MG/DL. A SECOND RESULT FROM METER B AT 14:10 WAS 120 MG/DL. A VENOUS SAMPLE WAS COLLECTED AT 14:50, AND THE RESULT WAS 142 MG/DL. A SECOND VENOUS SAMPLE WAS COLLECTED AT 15:13, AND THE RESULT WAS 132 MG/DL. THE PATIENT WAS GIVEN D50 AS A RESULT OF THE INITIAL QUESTIONABLE RESULT OF 67 MG/DL. IT WAS VERIFIED THAT THE PATIENT WAS NOT ADVERSELY AFFECTED BY THE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210550 ↗
• MalfunctionJan 28, 2026High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE GLUCOSE RESULT USING THE ACCU-CHEK INFORM II TEST STRIPS WITH TWO OF THE ACCU-CHEK INFORM II METERS + RF FOR ONE PATIENT. THE INITIAL RESULT WITH METER A AT 6:05 AM WAS 464 MG/DL. THE RESULT WITH METER B AT 6:15 AM WAS "HI", WHICH IS EQUIVALENT TO A RESULT THAT MAY BE GREATER THAN 600 MG/DL. A VENOUS SAMPLE WAS COLLECTED AT 6:29 AM, AND THE RESULT WAS 123 MG/DL. THE RESULT OF 123 MG/DL WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24201446 ↗
• MalfunctionJan 22, 2026Non Reproducible Results

  THE REPORTER COMPLAINED OF DISCREPANT GLUCOSE RESULTS FOR 1 PATIENT TESTED ON AN ACCU-CHEK INFORM II METER (METER 1) COMPARED TO A DIFFERENT ACCU-CHEK INFORM II METER (METER 2). THE PATIENT WAS INITIALLY TESTED WITH METER 1. AT 8:21 PM, METER 1 RESULT WAS 496 MG/DL, AND AT 8:23 PM, METER 1 RESULT WAS 234 MG/DL, WHILE AT 8:28 PM, METER 2 RESULT WAS 187 MG/DL. THE METER 2 RESULT OF 187 MG/DL WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24143371 ↗
• MalfunctionJan 20, 2026High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE GLUCOSE RESULT USING THE ACCU-CHEK INFORM II TEST STRIPS WITH TWO OF THE ACCU-CHEK INFORM II METERS + RF FOR ONE PATIENT. THE INITIAL RESULT AT 11:42 AM WITH METER A WAS 225 MG/DL. THE SECOND RESULT AT 11:44 AM WITH METER A WAS 151 MG/DL. THE THIRD RESULT AT 11:50 AM WITH METER B WAS 202 MG/DL. THE RESULTS OF 225 MG/DL AND 202 MG/DL WERE CONSIDERED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115496 ↗
• MalfunctionJan 2, 2026Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT GLUCOSE RESULTS FOR 1 PATIENT TESTED ON 2 ACCU-CHEK INFORM II METERS WITH SERIAL NUMBERS (B)(6) (METER A) AND (B)(6) (METER B). METER A WAS ALSO DISCREPANT WITH THE LABORATORY. AT 10:04 P.M., THE RESULT FROM METER A WAS 35 MG/DL. THE RESULT AT 10:10 P.M. WAS 37 MG/DL. AT 10:19 P.M., THE RESULT FROM THE LABORATORY WAS 121 MG/DL. AT 10:40 P.M., THE RESULT FROM METER A WAS 59 MG/DL. AT 10:46 P.M., THE RESULT FROM METER B WAS 83 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23942638 ↗
• MalfunctionDec 29, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM ACCUCHEK INFORM II METER SERIAL NUMBER (B)(6). AT 5:24 A.M., THE METER RESULT WAS 186 MG/DL. AT 7:17 A.M., THE METER RESULT WAS 148 MG/DL. AT 7:54 A.M., THE METER RESULT WAS 426 MG/DL. AT 7:56 A.M., THE METER RESULT WAS HI (>600 MG/DL). AT 8:16 A.M., THE METER RESULT WAS 198 MG/DL USING A NEW VIAL OF TESTING STRIPS. THE RESULT OF 198 MG/DL WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23909692 ↗
• MalfunctionDec 23, 2025High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT GLUCOSE RESULTS FOR ONE PATIENT TESTED WITH ACCU-CHEK INFORM II METER SERIAL NUMBER (B)(6). AT 6:52 A.M., A SAMPLE FROM THE PATIENT WAS TESTED ON THE METER, RESULTING IN A GLUCOSE VALUE OF 597 MG/DL. AT 6:54 A.M., A SAMPLE FROM THE PATIENT WAS TESTED ON THE METER, RESULTING IN A GLUCOSE VALUE OF 116 MG/DL. AT 6:55 A.M., A SAMPLE FROM THE PATIENT WAS TESTED ON THE METER, RESULTING IN A GLUCOSE VALUE OF 108 MG/DL. THE CUSTOMER WAS NOT SURE IF THE SAME FINGERSTICK WAS USED TO COLLECT SAMPLE FOR EACH MEASUREMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881976 ↗
• MalfunctionDec 22, 2025High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF A HIGH GLUCOSE RESULT NOT CORRESPONDING TO THE CLINICAL STATUS OF 1 PATIENT TESTED ON AN ACCU-CHEK INFORM II METER + RF. THE RESULT ON THE METER WAS "HI" (NUMERIC RESULT > 600 MG/DL). THIS RESULT DID NOT FIT THE PATIENT¿S HEALTH STATUS, AS THEY WERE ASYMPTOMATIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865716 ↗
• MalfunctionDec 22, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE GLUCOSE RESULT USING THE ACCU-CHEK INFORM II TEST STRIPS WITH THE ACCU-CHEK INFORM II METER + RF FOR ONE PATIENT. THE INITIAL RESULT AT 12:05 AM WAS 365 MG/DL. THE RESULT AT 12:07 AM ON AN UNKNOWN METER WAS 174 MG/DL. THE RESULT OF 174 MG/DL IS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863145 ↗
• MalfunctionDec 19, 2025No Device Output; High Test Results; No Device Output; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT GLUCOSE RESULTS FOR ONE PATIENT TESTED WITH ACCUCHEK INFORM II METER SERIAL NUMBERS (B)(6). AT 15:18, A SAMPLE FROM THE PATIENT WAS TESTED WITH METER SERIAL NUMBER (B)(6), RESULTING IN A GLUCOSE VALUE OF 46 MG/DL. AT 15:20, A SAMPLE FROM THE PATIENT WAS TESTED WITH METER SERIAL NUMBER (B)(6), RESULTING IN A GLUCOSE VALUE OF 90 MG/DL. AT 15:24, A SAMPLE FROM THE PATIENT WAS TESTED WITH METER SERIAL NUMBER (B)(6), RESULTING IN A GLUCOSE VALUE OF 56 MG/DL. AT 15:24, A SAMPLE FROM THE PATIENT WAS TESTED WITH METER SERIAL NUMBER (B)(6), RESULTING IN A GLUCOSE VALUE OF 101 MG/DL. THE CUSTOMER BELIEVED THE VALUE OF 101 MG/DL TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850945 ↗