Accu-Chek Inform II Instrument with RF cardRecalls & reported problems across all models

We found 2 models of Accu-Chek Inform II Instrument with RF card by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 50 adverse event reports in the FDA's MAUDE database, received between Aug 1, 2018 and Sep 25, 2026 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Patient Data Problem” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Accu-Chek Inform II Instrument with RF card problems

Accu-Chek Inform II Instrument with RF card models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Accu-Chek Inform II Instrument with RF card 5060303001

  SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
  46 reports
• Accu-Chek Inform II Instrument with RF card 04882458001

  System, Test, Blood Glucose, Over The Counter
  4 reports

Recent Accu-Chek Inform II Instrument with RF card adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Inaccurate Information

  There was an allegation of a software issue with the Accu-Chek Inform II meter. The customer alleged that the formatting of the critical range displayed on the meter could cause a misinterpretation of the result.The customer alleged that the ranges listed under "Ranges" are not the critical and/or reportable ranges but rather the acceptable ranges. Values that actually fall outside the displayed ranges would get flagged. The customer indicates that the ranges, as they currently display, are incorrect. There was no allegation of any actual misinterpretation of a result or of any patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895933 ↗
• MalfunctionSep 23, 2026Patient Data Problem

  The initial reporter complained of a patient data issue on an Accu-Chek Inform II meter with software version 04.05.00. The customer alleged that a patient result was tagged to the wrong patient ID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871471 ↗
• MalfunctionApr 24, 2026Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF A QUESTIONABLE GLUCOSE RESULT FOR ONE PATIENT TESTED WITH THE ACCU-CHEK INFORM II METER + RF. THE FIRST METER RESULT IS 429 MG/DL. A REPEAT TEST WAS PERFORMED IMMEDIATELY. THE SECOND METER RESULT IS 288 MG/DL. THIS RESULT IS WITHIN THE EXPECTED RANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24986979 ↗
• MalfunctionMar 30, 2026Device Sensing Problem

  THERE WAS AN ALLEGATION OF AN INCORRECT PATIENT'S DATE OF BIRTH BEING DISPLAYED WHEN THE PATIENT'S BARCODE WAS SCANNED ON AN ACCU-CHEK INFORM II METER. THE REPORTER STATED THAT THE BARCODE WAS A DEFAULT BARCODE USED FOR PATIENTS IN THE EMERGENCY ROOM. WHEN THE BARCODE WAS SCANNED, IT WAS SUPPOSED TO DISPLAY A DATE OF BIRTH OF "(B)(6) 1969", BUT THE METER ALLEGEDLY SHOWED A DATE OF BIRTH OF "(B)(6) 1969" INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713614 ↗
• MalfunctionMar 19, 2026Product Quality Problem; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED A QUESTIONABLE RESULT FROM THE ACCU-CHEK INFORM II METER. WHILE REVIEWING RESULTS FROM THE METER, THE CUSTOMER OBSERVED A RESULT OF 229 MG/DL AND A RESULT OF 109 MG/DL. THE CUSTOMER WAS ADAMANT THAT THE RESULT OF 229 MG/DL APPEARED ON ITS OWN AFTER THE STRIP HAD BEEN INSERTED AND ALLEGED THAT THE RESULT APPEARED WHEN NO SAMPLE HAD BEEN APPLIED. SHE ALLEGED THAT THE RESULT OF 109 MG/DL WAS THE ONLY ACTUAL PATIENT RESULT. THIS RESULT WAS NOT QUESTIONED. THE RESULT OF 229 MG/DL WAS OBTAINED AT 6:25 AM, AND THE RESULT OF 109 MG/DL WAS OBTAINED AT 6:26 AM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24636923 ↗
• MalfunctionFeb 19, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS FROM THE ACCU-CHEK INFORM II METER. ON (B)(6) 2026 AT 05:54, A GLUCOSE TEST WAS PERFORMED PRIOR TO THE PLANNED ORAL GLUCOSE TOLERANCE TEST (OGTT) TEST WITH A RESULT OF 175 MG/DL. THE PATIENT REPORTED THAT SHE HAD NEVER HAD SUCH A HIGH GLUCOSE LEVEL BEFORE. TWO FOLLOW-UP MEASUREMENTS WERE TAKEN FROM THE FINGER. AT 05:56, THE RESULT WAS 87 MG/DL, AND AT 05:58, THE RESULT WAS 127 MG/DL. A SAMPLE WAS TAKEN FROM A FLUORIDE PLASMA BLOOD SAMPLE, AND THE RESULT WAS 95.7 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24391799 ↗
• MalfunctionJan 5, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS FROM THE ACCU-CHEK INFORM II METER. AT 18:15, THE METER RESULT WAS 32.6 MMOL/L. AT 18:22, THE LABORATORY RESULT WAS 68.2 MMOL/L. AT 18:26, THE LABORATORY RESULT WAS >69 MMOL/L AND WAS CONSIDERED CRITICAL. AT 18:27, THE METER RESULT WAS 29.4 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956132 ↗
• MalfunctionDec 16, 2025Patient Data Problem; Patient Data Problem

  THE INITIAL REPORTER ALLEGED THERE WAS AN ISSUE WITH ACCU-CHEK INFORM II METER SERIAL NUMBERS (B)(6). WITH EACH METER, THE CUSTOMER ALLEGES THEY HAVE HAD AN ISSUE WHERE PATIENT RESULTS WERE TAGGED TO THE WRONG PATIENT IDENTIFIER. ON (B)(6) 2025 AT 07:04 A.M., A GLUCOSE TEST WAS PERFORMED ON PATIENT A (ID (B)(6) USING METER (B)(6). PATIENT A'S ID WAS CORRECTLY SCANNED AND RESULTED IN A VALUE OF 13.4 MMOL/L ON THE METER. THIS RESULT WAS TRANSMITTED TO THE CUSTOMER'S MIDDLEWARE SYSTEM AND LABORATORY INFORMATION SYSTEM (LIS) UNDER THE CORRECT PATIENT ID (ID ENDING WITH (B)(6). ON (B)(6) 2025 AT 07:07 A.M., A GLUCOSE TEST WAS PERFORMED ON PATIENT B USING METER (B)(6). PATIENT B (ID (B)(6) WAS CORRECTLY SCANNED AND RESULTED IN A VALUE OF 4.3 MMOL/L ON THE METER. WHEN THIS RESULT WAS TRANSMITTED TO THE CUSTOMER'S MIDDLEWARE AND LIS, IT WAS SOMEHOW TAGGED TO PATIENT A (ID (B)(6) INSTEAD. THE STAFF CHECKED THE METER AND FOUND THE 2 RESULTS (13.4 MMOL/L AND 3.2 MMOL/L) WERE BOTH TAGGED TO PATIENT A (ID (B)(6). THE RESULT FOR PATIENT B (ID (B)(6) COULD NOT BE FOUND ON THE METER. PATIENTS A AND B WERE IN DIFFERENT ROOMS. THERE WAS ANOTHER NURSE THAT WITNESSED THE STAFF PERFORMING THE TEST ON T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821768 ↗
• MalfunctionDec 8, 2025Patient Data Problem; Patient Data Problem

  THERE WAS AN ALLEGATION OF AN INSTANCE OF A PATIENT MISMATCH WHILE USING THE ACCU-CHEK INFORM II METER. AT 7:08 AM, A GLUCOSE TEST WAS PERFORMED ON PATIENT A USING THE METER, RESULTING IN 7.5 MMOL/L. THE RESULT WAS TAGGED TO THE CORRECT PATIENT ID IN THE METER AND TRANSMITTED CORRECTLY TO NAVIFY POINT OF CARE (POC). AT 7:12 AM, A GLUCOSE TEST WAS PERFORMED ON PATIENT B USING THE SAME METER, RESULTING IN 8.2 MMOL/L. THE TRANSMITTED DATA IN NAVIFY POC REFLECTED THAT THE RESULT WAS TAGGED INCORRECTLY TO PATIENT A'S ID. THE STAFF CHECKED THE METER AND FOUND THAT BOTH 8.2 MMOL/L AND 7.5 MMOL/L RESULTS WERE TAGGED TO PATIENT A'S ID, WHILE PATIENT B'S RESULT WITH PATIENT B'S ID CANNOT BE FOUND IN THE METER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741139 ↗
• MalfunctionNov 25, 2025Insufficient Device Problem Information; Patient Data Problem; Insufficient Device Problem Information; Patient Data Problem

  THERE WAS AN ALLEGATION OF AN INSTANCE OF A PATIENT MISMATCH WHILE USING THE ACCU-CHEK INFORM II METER. AT 5:03 PM, A GLUCOSE TEST WAS PERFORMED ON PATIENT A AT BED 20 (PATIENT ID: (B)(6)) USING THE METER, RESULTING IN 11.3 MMOL/L. THE RESULT WAS TAGGED TO THE CORRECT PATIENT ID IN THE METER AND TRANSMITTED CORRECTLY. AT 5:05 PM, A GLUCOSE TEST WAS PERFORMED ON PATIENT B AT BED 22 (PATIENT ID: (B)(6)) USING THE SAME METER, RESULTING IN 6.2 MMOL/L. THE STAFF CHECKED THE METER AND FOUND THAT THE RESULT WAS TAGGED INCORRECTLY TO PATIENT A'S ID (B)(6) IN THE METER AND TRANSMITTED UNDER ID (B)(6). THE 2 PATIENTS WERE IN THE SAME ROOM, AND BOTH TESTS WERE PERFORMED BACK-TO-BACK BY THE SAME STAFF MEMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647443 ↗
• MalfunctionNov 11, 2025Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION OF QUESTIONABLE GLUCOSE RESULTS FOR ONE PATIENT TESTED WITH THE ACCU-CHEK INFORM II METER + RF. THE FIRST METER RESULT WAS 8 MMOL/L. THE SECOND METER RESULT WAS 4 MMOL/L. THE TIME INTERVAL BETWEEN THE TESTS WAS LESS THAN FIFTEEN MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520730 ↗
• MalfunctionNov 10, 2025Patient Data Problem; Patient Data Problem

  THERE WAS AN ALLEGATION OF TWO INSTANCES OF A PATIENT MISMATCH WHILE USING THE ACCU-CHEK INFORM II METERS. EVENT 1 (B)(6) 2025): AT 11:35 AM, A GLUCOSE TEST WAS PERFORMED ON PATIENT A (ID (B)(6) USING METER (B)(6). PATIENT A'S ID WAS CORRECTLY SCANNED, AND A RESULT OF 9.1 MMOL/L WAS OBTAINED ON THE METER. THIS RESULT WAS TRANSMITTED AND REPORTED UNDER THE CORRECT PATIENT ID. AT 11:39 AM, A GLUCOSE TEST WAS PERFORMED ON PATIENT B (ID (B)(6) USING METER (B)(6). PATIENT B'S ID WAS CORRECTLY SCANNED, AND A RESULT OF 5.5 MMOL/L WAS OBTAINED ON THE METER. WHEN THIS RESULT WAS TRANSMITTED, IT WAS SOMEHOW TAGGED TO PATIENT A (ID (B)(6). THE STAFF CHECKED THE METER AND FOUND THAT THE RESULTS (9.1 MMOL/L AND 5.5 MMOL/L) WERE BOTH TAGGED TO PATIENT A (ID (B)(6). NO RESULT FOR PATIENT B (ID (B)(6) COULD BE FOUND ON THE METER. EVENT 2 (26-SEP-2025): AT 7:12 PM, A GLUCOSE TEST WAS PERFORMED ON PATIENT C (ID (B)(6) USING METER (B)(6). PATIENT C'S ID WAS CORRECTLY SCANNED, AND A RESULT OF 12.7 MMOL/L WAS OBTAINED ON THE METER. THIS RESULT WAS TRANSMITTED AND REPORTED UNDER THE CORRECT PATIENT ID. AT 7:15 PM, A GLUCOSE TEST WAS PERFORMED ON PATIENT D (ID (B)(6) USING METER (B)(6). PATIENT D'S ID WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23509996 ↗
• MalfunctionSep 19, 2025Patient Data Problem; Patient Data Problem

  WE RECEIVED AN ALLEGATION OF A PATIENT MISMATCH FROM A CUSTOMER USING THE ACCU-CHEK INFORM II METER. AT 7:52 AM, PATIENT A WAS TESTED AND HAD A RESULT OF 7.9 MMOL/L. THE PATIENT'S BARCODED WRIST TAG WAS CORRECTLY SCANNED, AND THE CORRECT RESULT WAS TRANSMITTED TO THE LABORATORY INFORMATION SYSTEM (LIS). AT 7:58 AM, PATIENT B WAS TESTED AND HAD A RESULT OF 14.9 MMOL/L. THE PATIENT'S BARCODED WRIST TAG WAS CORRECTLY SCANNED, BUT THE RESULT WAS INCORRECTLY TRANSMITTED TO THE LIS; THE RESULT WAS TAGGED TO PATIENT A. THE CUSTOMER CHECKED THE METER AND FOUND THE RESULTS OF 7.9 MMOL/L AND 14.9 MMOL/L TAGGED TO PATIENT A. THE RESULT OF PATIENT B COULD NOT BE FOUND ON THE METER. THE STAFF CONFIRMED THAT THE RESULT DOES NOT BELONG TO PATIENT A, AS PATIENT B IS DIABETIC AND REQUIRES INSULIN DAILY. THE CUSTOMER RULED OUT INCORRECT BARCODES AND SCANNING AND CONFIRMED THAT THEY FOLLOWED THE CORRECT WORKFLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096551 ↗
• MalfunctionSep 17, 2025Output Problem; Non Reproducible Results; Output Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE GLUCOSE RESULT WITH ACCU-CHEK INFORM II TEST STRIPS FROM THE ACCU-CHEK INFORM II METER + RF FOR ONE PATIENT. THE INITIAL RESULT AT 10:04 P.M. WAS 135 MG/DL. A VENOUS SAMPLE FROM 11:10 P.M. HAD A RESULT OF 119 MG/DL. THE SECOND RESULT AT 11:24 P.M. WAS "HI". THE THIRD RESULT AT 11:26 P.M. WAS 540 MG/DL. THE FOURTH RESULT AT 11:30 P.M. WAS 155 MG/DL. THE PATIENT WAS RECEIVING A GLUCOSE IV, AND THE RESULTS OF "HI" AND 540 MG/DL WERE FROM SAMPLES COLLECTED FROM THE FINGERTIPS OF THE ARM WITH THE IV. THE RESULT OF 155 MG/DL WAS BELIEVED TO BE CORRECT. THERE WAS NO TREATMENT RECEIVED BASED ON THE QUESTIONABLE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075935 ↗
• MalfunctionSep 17, 2025Device Sensing Problem; Device Sensing Problem

  THE INITIAL REPORTER STATED THERE ARE THREE ISSUES WITH THE SOFTWARE OF ACCU-CHEK INFORM II METER SERIAL NUMBER (B)(6). ISSUE 1: THE CUSTOMER ALLEGES THAT THE METER IS CONFIGURED TO USE A VALID PATIENT ID LIST AND IT IS ALSO CONFIGURED TO MASK BARCODES. THE CUSTOMER CLAIMS THAT THE TEST STRIP VIAL WAS SCANNED BY THE METER IN PLACE OF A PATIENT ID AND A METER RESULT COULD BE OBTAINED FOR A PATIENT. THE CUSTOMER CLAIMS THAT THE METER SHOULD NOT HAVE ALLOWED A PATIENT RESULT TO BE OBTAINED WITH THE CURRENT PATIENT ID MASKING CONFIGURATION. ISSUE 2: THE CUSTOMER ALLEGES THAT THE METER ALLOWED USE OF AN OPERATOR ID AND IT SHOULD NOT HAVE ALLOWED THIS DUE TO THE MASKING CONFIGURATION ON THE METER. ISSUE 3: THE CUSTOMER ALLEGES THAT THE METER ALLOWED PATIENT TESTING BETWEEN (B)(6) 2025 WITHOUT REQUIRING ANY CONTROLS. THE LAST PASSING CONTROLS WERE RUN ON (B)(6) 2025 FOR THIS METER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23075792 ↗

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