Accu-Chek Inform II Instrument with RF card 5060303001Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 04015630925469), received between Aug 1, 2018 and Sep 25, 2026 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (11 reports).

3 other recalls cover devices cleared under the same FDA submission (K121679); 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 25 most recent of 46 reports, 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 ↗
• MalfunctionAug 1, 2025Patient Data Problem; Patient Data Problem

  THERE WAS AN ALLEGATION OF A SOFTWARE ISSUE WITH AN ACCU-CHEK INFORM II METER + RF. FOR 1 PATIENT, THE DATE OF BIRTH ON THE METER DID NOT CORRESPOND TO THE DATE OF BIRTH THAT WAS USED WHEN THE PATIENT WAS REGISTERED. THE PATIENT WAS ADMITTED THROUGH THE EMERGENCY ROOM AS AN UNKNOWN PATIENT WITH A DATE OF BIRTH OF "(B)(6) 1900." IT IS THE EMERGENCY ROOM¿S PROCEDURE TO USE THE YEAR 1900 FOR UNKNOWN PATIENTS, AS UNKNOWN PATIENTS SHOULD BE 125 YEARS OLD. THE CLERK ENTERING THE DATE USES VARIOUS MONTHS/DAYS TO CREATE THESE DATES. THE DATE OF BIRTH IN THE HOSPITAL SYSTEM AND THE COBAS INFINITY SOFTWARE CORRESPOND TO THE DATE OF BIRTH OF "(B)(6) 1900" USED AT REGISTRATION. THE PATIENT¿S DATE OF BIRTH ON THE INFORM METER IS SHOWING AS "(B)(6) 1969." THE DATE OF BIRTH CANNOT BE MANIPULATED AT THE METER LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22688903 ↗
• MalfunctionJun 5, 2025Patient Data Problem; Patient Data Problem

  THE INITIAL REPORTER STATED THERE WAS AN ISSUE WITH AN ALLEGED PATIENT RESULT MISMATCH WHEN USING ACCU-CHEK INFORM II METER SERIAL NUMBER (B)(6). AT 7:04 A.M., OPERATOR A PERFORMED A GLUCOSE TEST ON PATIENT A (WITH IDENTIFIER ENDING WITH (B)(6) WITH THE METER. PATIENT AN ID WAS CORRECTLY SCANNED AND RESULTED 11.0 MMOL/L ON THE METER. THIS RESULT WAS TRANSMITTED TO THE CUSTOMER'S LABORATORY INFORMATION SYSTEM (LIS) UNDER THE CORRECT PATIENT ID (ID ENDING WITH (B)(6). AT 7:07 A.M., OPERATOR B PERFORMED A GLUCOSE TEST ON PATIENT B (ID ENDING WITH (B)(6) USING THE METER. PATIENT B ID WAS CORRECTLY SCANNED AND RESULTED 7.7 MMOL/L ON THE METER. WHEN THIS RESULT WAS TRANSMITTED TO THE LIS, IT WAS SOMEHOW TAGGED TO PATIENT A'S ID (ENDING WITH (B)(6) INSTEAD. OPERATOR B CHECKED ON THE METER AND FOUND THAT 2 RESULTS (11.0 MMOL/L AND 7.7 MMOL/L) WERE BOTH TAGGED TO PATIENT A'S ID (ENDING WITH (B)(6). THE RESULT FOR PATIENT B (ID ENDING WITH (B)(6) COULD NOT BE FOUND ON THE METER. THE NURSE IN CHARGE CONFIRMED THAT THE RESULT OF 7.7 MMOL/L DOES NOT BELONG TO PATIENT A AS THE EXPECTED GLUCOSE RESULT FOR PATIENT A IS AROUND 10-11 MMOL/L AND A DECREASE OF 3.3 MMOL/L WITHIN 3 MINUTES WAS DEEMED NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22150471 ↗
• MalfunctionApr 21, 2025Device Sensing Problem; Device Sensing Problem

  THERE WAS AN ALLEGATION OF AN ACCU-CHEK INFORM II METER + RF THAT INCORRECTLY SCANNED A PATIENT ID AND THEN FLAGGED IT AS NOT BEING A VALID PATIENT ID. THE CUSTOMER COMPLETED TESTING WITHOUT A PATIENT NAME OR BIRTHDAY, AND THE RESULTS DID NOT GO INTO A MEDICAL RECORD AS THEY WERE FLAGGED AS NOT BEING A VALID PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21874503 ↗
• MalfunctionApr 3, 2025Communication or Transmission Problem; Device Sensing Problem; Communication or Transmission Problem; Device Sensing Problem

  THERE WAS AN ALLEGATION OF A BARCODE SCANNING ISSUE WITH AN ACCU-CHEK INFORM II METER + RF. THE CUSTOMER ALLEGED THAT WHEN SCANNING A PATIENT¿S ID, THE INFORMATION IN THE LABORATORY INFORMATION SYSTEM (LIS) WAS FOR A DIFFERENT PATIENT ID THAT IS NO LONGER IN THE FACILITY. THE RESULT FOR THE CURRENT PATIENT ID WAS FROM (B)(6) 2025, 104 MG/DL AT 11:58 A.M. THE PATIENT ID ASSOCIATED WITH THIS RESULT WAS FOR A PATIENT WHO IS NO LONGER IN THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21760928 ↗
• MalfunctionMar 13, 2025Device Sensing Problem; Device Sensing Problem

  THERE WAS AN ALLEGATION OF A PATIENT ID THAT WAS SCANNED BY THE ACCU-CHEK INFORM II METER + RF AS A DIFFERENT PATIENT ID. THE PATIENT ID SCANNED WAS (B)(6) AND THE PATIENT ID DISPLAYED IN THE COBAS INFINITY AS (B)(6) AND WAS FLAGGED AS NOT MATCHING. THE INCORRECT ID WAS A LEGITIMATE PATIENT ID IN THEIR SYSTEM, HOWEVER, THAT PATIENT WAS NOT HOSPITALIZED AT THE TIME OF THE EVENT. THERE WAS NO HARM TO ANY PATIENT RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593222 ↗
• MalfunctionMar 13, 2025Device Sensing Problem; Device Sensing Problem

  THERE WAS AN ALLEGATION OF A PATIENT ID THAT WAS SCANNED BY THE ACCU-CHEK INFORM II METER + RF AS A DIFFERENT PATIENT ID. THE PATIENT ID SCANNED WAS (B)(6) AND THE PATIENT ID DISPLAYED IN THE COBAS INFINITY AS (B)(6) AND WAS FLAGGED AS NOT MATCHING. THE SAME ISSUE OCCURRED ON (B)(6)2025 WITH THE SAME PATIENT ID ON THE SAME METER BUT WITH A DIFFERENT OPERATOR. THE INCORRECT ID WAS A LEGITIMATE PATIENT ID IN THEIR SYSTEM, HOWEVER, THAT PATIENT WAS NOT HOSPITALIZED AT THE TIME OF THE EVENT. THERE WAS NO HARM TO ANY PATIENT RELATED TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21593215 ↗
• MalfunctionMar 6, 2025Display Difficult to Read; Display Difficult to Read

  THERE WAS AN ALLEGATION OF A QUESTIONABLE GLUCOSE RESULT FROM THE ACCU-CHEK INFORM II METER + RF. DUE TO A DISPLAY ISSUE OF A LARGE BLACK SPLOTCH IN THE UPPER LEFT SECTION, A RESULT OF 155 MG/DL WAS MISINTERPRETED AS 55 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21535929 ↗
• MalfunctionFeb 18, 2025Device Sensing Problem; Device Sensing Problem

  THE INITIAL REPORTER COMPLAINED OF INTERMITTENT BARCODE SCANNING ISSUES WITH APPROXIMATELY 5 ACCU- CHEK INFORM II INSTRUMENTS WITH RF CARD. THE CUSTOMER PROVIDED A SERIAL NUMBER FOR 1 METER. THE CUSTOMER ALLEGED THE METER SCANS UNEXPECTED DIGITS WHEN SCANNING PATIENT ID BARCODES. THE CUSTOMER ALLEGES THE METER SHOWS TESTS BEING RUN ON PATIENT IDS WHO ARE NO LONGER IN THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21393302 ↗
• MalfunctionNov 21, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED QUESTIONABLE GLUCOSE RESULTS FROM ONE PATIENT TESTED WITH THE ACCU-CHEK INFORM II METER. THE FIRST RESULT AT 7:37 AM WAS 26.0 MMOL/L. THE SECOND RESULT AT 7:38 AM FROM THE SAME SITE AS THE FIRST RESULT WAS 18.4 MMOL/L. THE THIRD RESULT AT 7:39 AM FROM THE SAME SITE AS THE FIRST RESULT WAS 9.3 MMOL/L. THE RESULT AT 7:42 AM WAS 6.8 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20749590 ↗
• MalfunctionAug 7, 2024Output Problem; Output Problem

  THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FROM ACCUCHEK INFORM II METER, SERIAL NUMBER (B)(6) , COMPARED TO A COBAS C503 ANALYZER AND AN UNKNOWN BLOOD GAS ANALYZER. AT 10:00 A.M., THE METER RESULT WAS 50. AT 10:10 A.M., THE METER RESULT WAS 51. AT 10:15 A.M., THE METER RESULT WAS 54. A SAMPLE WAS ALLEGEDLY MEASURED "IMMEDIATELY" ON A COBAS C503 ANALYZER AND A BLOOD GAS ANALYZER. THE COBAS C503 ANALYZER GLUCOSE RESULT WAS 693 AND THE BLOOD GAS ANALYZER RESULT WAS 690. THE UNITS OF MEASUREMENT WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19927087 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121679. One submission often covers many models, so check the product and lot details in each record.

• Z-2354-2021 · Jul 28, 2021 · Open, Classified
  Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
• Z-1172-2016 · Feb 11, 2016 · Terminated
  Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outsi
• Z-1113-2013 · Mar 6, 2013 · Terminated
  ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively measure glucose (sugar).