McKesson 06-RE4051P-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20612479197217), received between Feb 17, 2017 and Aug 7, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “High Test Results” (9 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Mar 27, 2026Class IOpen, Classified

   Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment. This is a downstream recall of Trividia Health Class I, Recall Event ID 98317.

   Z-1947-2026 · Root cause: Component design/selection · Recall details · FDA record ↗

2. Feb 6, 2026Class IOpen, Classified

   The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose.

   Z-1546-2026 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2025Failure to Power Up; Failure to Power Up

  CONSUMER REPORTED COMPLAINT FOR DEAD METER. CUSTOMER STATED THAT SHE HAD DROPPED THE METER IN WATER AND THAT IT IS NOT WORKING. CUSTOMER IS USING TRUE METRIX PRO METER WHICH IS FOR MULTIPLE PATIENT USE. THE CUSTOMER REPORTED FEELING WEAK; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. THE CUSTOMER STATED SHE HAS NOT TESTED IN 3 MONTHS "BECAUSE SHE COULDN'T USE THE METER." TEST STRIP LOT INFORMATION WAS NOT PROVIDED; CUSTOMER WAS UNABLE TO LOCATE THE TEST STRIPS. CUSTOMER WAS PROVIDED WITH REPLACEMENT TRUE METRIX PRODUCTS.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 22742534 ↗
• InjuryNov 18, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  CONSUMER REPORTED COMPLAINT THAT THE METER WAS NOT WORKING WITH THE TEST STRIPS. CUSTOMER IS USING TRUE METRIX PRO METER WHICH IS INTENDED FOR MULTI-PATIENT USE. CUSTOMER WAS ALSO USING ANOTHER BRAND OF STRIPS WITH THE METER. AT THE TIME OF THE CALL THE CUSTOMER REPORTED SYMPTOMS OF BLURRY VISION AND LEG SWELLING. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. TRUE METRIX PRODUCT LINE REPLACEMENTS WERE SENT TO CUSTOMER.

  Patient problems: Blurred Vision; Swelling/ Edema

  MAUDE report 15824627 ↗
• InjuryJan 15, 2021Insufficient Device Problem Information

  CONSUMER HAD CALLED FOR TRAINING ON PERFORMING A BLOOD TEST. DURING THE CALL A BLOOD TEST WAS PERFORMED BY THE CUSTOMER FASTING AND PRODUCED TEST RESULT OF 52 MG/DL USING THE METER. CUSTOMER WAS NOT CONCERNED WITH THE RESULT. CUSTOMER STATED THAT SHE HAS A POOR DIET AND HAS NOT BEEN EATING. AT THE TIME OF THE CALL, THE CUSTOMER REPORTED FEELING SHAKY BUT MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. CUSTOMER HAD NO FURTHER CONCERNS REGARDING THE PRODUCT.

  Patient problems: Shaking/Tremors; Urinary Frequency / Polyuria

  MAUDE report 11181464 ↗
• MalfunctionJan 11, 2021Failure to Power Up; Battery Problem; Failure to Power Up; Battery Problem

  CONSUMER REPORTED COMPLAINT FOR NO RESPONSIVE-DEAD METER. CUSTOMER IS USING THE PROFESSIONAL VERSION, A METER THAT IS INTENDED FOR FACILITY USE. DURING THE CALL THE CUSTOMER REPORTED SYMPTOMS OF BLURRY VISION, EXCESSIVE THIRST, FREQUENT URINATION AND LETHARGY; MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME. CUSTOMER STATED SHE HAD OBTAINED THE TRUEMETRIX PRO METER (B)(6) 2020 AND THE BATTERY HAD NEVER BEEN CHANGED. THE BATTERY IS CORRECT FOR THE METER AND WAS IN THE CORRECT ORIENTATION. DURING THE CALL THE TRUEMETRIX PRO METER DID NOT POWER ON USING THE POWER BUTTON OR WHEN A TEST STRIP WAS INSERTED. CUSTOMER WAS SENT A REGULAR METER AS REPLACEMENT.

  Patient problems: Blurred Vision; Lethargy; Polydipsia; Urinary Frequency / Polyuria

  MAUDE report 11147313 ↗
• MalfunctionJul 23, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI DISPLAY. NURSE FROM URGENT CARE FACILITY IS CALLING ON BEHALF OF THE CUSTOMER. THE EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. CUSTOMER WAS HAVING SYMPTOMS. SYMPTOMS WERE NOT DISCLOSED. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 02/29/2020 AND OPEN VIAL DATE IS UNDISCLOSED. THE FACILITY'S METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Information

  MAUDE report 8818305 ↗
• MalfunctionMay 22, 2019High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI DISPLAY. STAFF IS CALLING ON BEHALF OF THE EVP BOULDER CREEK FACILITY REGARDING THE METER IS READING HI. THE CUSTOMER DID NOT REPORT SYMPTOMS. MEDICAL ATTENTION IS NOT REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS. THE PRODUCT STORAGE LOCATION IS UNDISCLOSED. DURING THE CALL A BLOOD TEST WAS NOT PERFORMED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 09/30/2019 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8633647 ↗
• MalfunctionApr 19, 2019Unable to Obtain Readings; Unable to Obtain Readings

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR: TEST STRIP ERROR. THE E-5 ERROR OCCURRED WHEN THE BLOOD SAMPLE WAS ABSORBED. AT THE TIME OF THE CALL THE CUSTOMER WAS NOT FEELING WELL. CUSTOMER STATED SHE FELT SOME WEAKNESS AND WAS NOT AS STEADY ON HER FEET AND WAS HAVING FREQUENT URINATION, SHE WAS FEELING THAT WAY SINCE LAST NIGHT. MEDICAL ATTENTION WAS NOT NEEDED AT THE TIME OF THE CALL. CUSTOMER STATED SHE WOULD TAKE HER INSULIN AS SCHEDULED. DURING THE CALL ON A BLOOD TEST WAS PERFORMED BY THE CUSTOMER AND PRODUCED TEST RESULT OF E-5 USING METER. NO ADVERSE EVENT OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Urinary Frequency / Polyuria; Weakness

  MAUDE report 8532364 ↗
• MalfunctionFeb 15, 2019High Test Results; High Test Results

  CUSTOMER STATES THE METER IS READING HI DISPLAY AND ONLY CONCERNED WITH THIS. NURSE CALLING ON BEHALF OF FACILITY STATES THAT METER WAS READING HI ON THEIR PATIENT. NURSE STATES THAT SHE CANNOT DISCLOSE HOW CUSTOMER IS FEELING AT TIME OF CALL BECAUSE THAT PATIENT WAS NOT WITH NURSE AT TIME OF CALL. NURSE DECLINED TO GO THROUGH HISTORY OF METER DUE TO HER HAVING OTHER PATIENTS TO ATTEND TO. CUSTOMER DID STATE BECAUSE THEY WERE ONLY RECEIVING HI ON METER DOCTOR IS HAVING CUSTOMER GO TO EMERGENCY ROOM. CUSTOMER STATES THEIR NORMAL FASTING RANGE IS 70 MG/DL-100MG/DL FASTING. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE MEDICINE CABINET. DURING THE CALL ON (B)(6) 2019, A BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 10/25/2019 AND OPEN VIAL DATE IS (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8343704 ↗
• MalfunctionDec 19, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HI BLOOD GLUCOSE TEST RESULTS. LAB SUPERVISOR IS CALLING ON BEHALF OF THE CUSTOMER; LAB SUPERVISOR WOULD NOT DISCLOSE CUSTOMER'S NAME. THE CUSTOMER IS CONCERNED WITH TEST RESULTS FROM RESULTS OBTAINED OF HI. LAB SUPERVISOR DECLINED TO PROVIDE THE CUSTOMER'S EXPECTED BLOOD GLUCOSE TEST RESULT RANGE. LAB SUPERVISOR STATED THAT ON (B)(6) 2017 WHEN TESTING CUSTOMER, A RESULT OF HI HAD BEEN OBTAINED. THE CUSTOMER WAS THEN ADMITTED TO THE HOSPITAL DUE TO THE HI RESULT AND SYMPTOMS OF FREQUENT URINATION AND WEIGHT LOSS. WHEN AT THE HOSPITAL, THE CUSTOMER'S GLUCOSE LEVEL WITH THE HOSPITAL'S METER WAS 350 MG/DL NON-FASTING; CUSTOMER RECEIVED AN IV AND AFTER TWO-THREE HOURS HAD RECEIVED A GLUCOSE RESULT OF 429 MG/DL NON-FASTING WITH THE HOSPITAL'S METER. LAB SUPERVISOR STATED THE PATIENT RECEIVED TREATMENTS WHILE IN THE HOSPITAL ON (B)(6) 2017 BUT DOES NOT KNOW THE SPECIFIC TREATMENTS THAT WERE GIVEN. LAB SUPERVISOR COULD NOT CONTINUE THE PHONE CONVERSATION DUE TO RESTRICTED TIME AND DECLINED TO ANSWER FURTHER QUESTIONS. DURING THE CALL ON (B)(6) 2017, A BACK TO BACK BLOOD TEST WAS NOT PERFORMED BY THE CUSTOMER. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION

  Patient problems: Urinary Frequency / Polyuria; Weight Changes

  MAUDE report 7130021 ↗
• MalfunctionNov 17, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR HIGH CONTROL GLUCOSE TEST RESULTS. HEALTHCARE PROVIDER FROM A HEALTHCARE FACILITY IS CALLING. THE CUSTOMER IS CONCERNED WITH CONTROL TEST RESULTS FROM RESULTS OBTAINED OF 65 AND 60 MG/DL. CONTROL TESTS NOT WITHIN ACCEPTABLE RANGE OF 25 - 55 MG/DL. CONTROL LEVEL ONE, LOT# 7BC1A20, MANUFACTURER'S EXPIRATION DATE IS 12/31/2018 AND OPEN DATE IS (B)(6) 2017. THE PRODUCT IS STORED ACCORDING TO SPECIFICATION IN THE LAB AT THE FACILITY. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 08/23/2018 AND OPEN VIAL DATE IS (B)(6) 2017. THE METER MEMORY WAS NOT REVIEWED FOR PREVIOUS TEST RESULT HISTORY. (B)(6) (HEALTHCARE PROVIDER) CALLING IN ON BEHALF OF (B)(6) CALLED IN STATES THE METER FOR CONTROL SOLUTIONS IS READING HIGH RESULT READ 65 MG/DL LEVEL 1 LOT#7BC1A20 RANGE 25MG/DL-55 MG/DL ALSO CONTROL SOLUTIONS IS READING HIGH RESULT READ 60 MG/DL LEVEL 1 LOT#7BC1A20 RANGE 25MG/DL-55 MG/DL. CONTROL SOLUTIONS AND TEST STRIPS WERE STORED IN LAB AND WEREN'T COMPROMISED. IT IS A FACILITY AND THEY WERE ADVISED TO DISCONTINUE THE USE OF THIS METER AND TEST STRIPS AND TO PLEASE RETURN SUPPLIES TO US FOR INVESTIGATION. WILL FOLLOW UP WITH FACILITY FOR CUSTOMER SATISFAC

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7042506 ↗
• MalfunctionApr 6, 2017High Test Results; Device Displays Incorrect Message; High Test Results; Device Displays Incorrect Message

  CONSUMER REPORTED COMPLAINT FOR HIGH BLOOD GLUCOSE TEST RESULTS, MULTIPLE ERROR CODES AND MEDICAL ATTENTION. (B)(6)-SUPPORT MANAGER, IS EMAILING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF 126 AND 142MG/DL. THE PRODUCT IS STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 04/30/2018 AND OPEN VIAL DATE IS UNDISCLOSED. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY (DATE / TIME NOT SET): (B)(6). CONCERNS ARE THE 126 AND THE 142MG/DL FROM THE METER'S MEMORY. THIS WAS AN EMAIL. THE REPORT HAVING A PATIENT WHO WAS PRESENTING WITH SIGNS OF STROKE. TESTING THE PATIENT'S BLOOD GLUCOSE IN THE AMBULANCE WITH THIS METER AND GETTING A RESULT OF 126MG/DL. WHEN THEY GOT TO THE EMERGENCY ROOM, THE BLOOD GLUCOSE WAS RE-CHECKED WITH THE HOSPITAL SYSTEM (UNKNOWN AS TO WHAT SYSTEM IS) AND THE BLOOD GLUCOSE RESULT WAS 26MG/DL FOR WHICH THE PATIENT REQUIRED IMMEDIATE TREATMENT FOR SEVER HYPOGLYCEMIA. THE DATE WAS POSSIBLY (B)(6) 2017, AND THERE IS SUCH A RESULT IN THIS METER FOR THAT DATE. THEY ALSO REPORTED ANOTHER INCIDENT WITH THIS METER WHERE THE BLOOD GLUCOSE OF THE PATIENT TESTES IN THE AMBULAN

  Patient problems: Hypoglycemia

  MAUDE report 6463892 ↗
• MalfunctionMar 14, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR MESSAGE ACCOMPANIED BY SYMPTOMS. (B)(6) (PARAMEDIC) IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF E-5 AND SYMPTOMS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF ALTERED MENTAL STATUS AND UNRESPONSIVE ON ARRIVAL. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 12/24/2017 AND OPEN VIAL DATE IS ABOUT ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY:" (B)(6). SYMPTOMS:-PARAMEDIC IS CALLING FOR HIS PATIENT. CUSTOMER STATES THAT HE WAS CALLED TO THE SCENE FOR HIS PATIENT DISPLAYING "ALTERED MENTAL STATUS". WHEN HE ARRIVED, THE CUSTOMER WAS UNRESPONSIVE. CUSTOMER CALLED TO ASK WHAT THE E-5 MEANT. I EXPLAINED THAT IT COULD BE A TEST STRIP ERROR OR THE BLOOD GLUCOSE BEING ABOVE 600MG/DL. CUSTOMER STATES THAT HE IS UPSET BECAUSE HE WOULD HAVE LIKED THE METER TO READ HI RATHER THAN E-5 SO HE WOULDN'T HAVE TO DOUBT WHETHER IT'S THE STRIP OR T

  Patient problems: Confusion/ Disorientation

  MAUDE report 6404680 ↗
• MalfunctionMar 14, 2017High Test Results; High Test Results

  CONSUMER REPORTED COMPLAINT FOR E-5 ERROR MESSAGE ACCOMPANIED BY SYMPTOMS. (B)(6)(PARAMEDIC) IS CALLING ON BEHALF OF THE CUSTOMER. THE CUSTOMER IS CONCERNED WITH TESTS RESULTS FROM RESULTS OBTAINED OF E-5 AND SYMPTOMS. THE CUSTOMER'S EXPECTED FASTING BLOOD GLUCOSE TEST RESULT RANGE IS UNDISCLOSED. THE CUSTOMER DID REPORT SYMPTOMS OF ALTERED MENTAL STATUS AND UNRESPONSIVE ON ARRIVAL. MEDICAL ATTENTION IS REPORTED AS A RESULT OF THE ACTUAL BLOOD GLUCOSE RESULTS AND REPORTED SYMPTOMS. THE PRODUCT IS STORAGE LOCATION IS UNDISCLOSED. THE TEST STRIP LOT MANUFACTURER'S EXPIRATION DATE IS 03/30/2018 AND OPEN VIAL DATE IS ABOUT ONE MONTH AGO. THE METER MEMORY WAS REVIEWED FOR PREVIOUS TEST RESULT HISTORY:" (B)(6). SYMPTOMS: PARAMEDIC IS CALLING FOR HIS PATIENT. CUSTOMER STATES THAT HE WAS CALLED TO THE SCENE FOR HIS PATIENT DISPLAYING "ALTERED MENTAL STATUS". WHEN HE ARRIVED, THE CUSTOMER WAS UNRESPONSIVE. CUSTOMER CALLED TO ASK WHAT THE E-5 MEANT. I EXPLAINED THAT IT COULD BE A TEST STRIP ERROR OR THE BLOOD GLUCOSE BEING ABOVE 600 MG/DL. CUSTOMER STATES THAT HE IS UPSET BECAUSE HE WOULD HAVE LIKED THE METER TO READ HI RATHER THAN E-5 SO HE WOULDN'T HAVE TO DOUBT WHETHER IT'S THE STRIP OR T

  Patient problems: Confusion/ Disorientation

  MAUDE report 6403683 ↗
• MalfunctionFeb 17, 2017High Test Results; Device Operates Differently Than Expected; High Test Results; Device Operates Differently Than Expected

  (B)(6) A PARAMEDIC FROM THE (B)(6) REPORTED COMPLAINT FOR INACCURATE BLOOD GLUCOSE TEST RESULTS DURING AND EMERGENCY CALL. CUSTOMER STATES THAT HE ARRIVED TO THE SCENE OF A FEMALE WHO WAS UNCONSCIOUS. PER (B)(6), A BLOOD GLUCOSE RESULT OF 136MG/DL WAS OBTAINED BY THE TEAMS TRUEMETRIX PRO METER. CUSTOMER STATES THAT IT IS NOT KNOWN WHETHER OR NOT THAT WAS A FASTING GLUCOSE; HOWEVER, THE METER SHOWED THE CONTROL SOLUTION SYMBOL WHEN THE RESULT OF 136MG/DL WAS OBTAINED WITH THE CUSTOMER'S BLOOD. PER (B)(6), THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE SHE OBTAINED A GLUCOSE READING OF 23MG/DL. TIME BETWEEN THE PARAMEDIC BLOOD GLUCOSE TEST AND THE HOSPITAL BLOOD GLUCOSE TEST IS NOT SPECIFIED. (B)(6) DOES NOT KNOW IF THAT WAS OBTAINED WITH A HAND HELD GLUCOSE METER OR VIA LAB TEST. CUSTOMER STATED THAT "SINCE THE READING WAS 136MG/DL ON THE GLUCOSE METER, THEY DID NOT ADMINISTER IV D50 THUS LEADING THE CUSTOMER TO BE INTUBATED AT THE HOSPITAL. FURTHER INFORMATION ON CUSTOMER CURRENT CONDITION UNKNOWN. (B)(6) STATED THAT HE DOES NOT HAVE THE INFORMATION (SN NUMBER LOT NUMBER) REGARDING THE METER AND STRIPS AS IT HAS BEEN PLACED IN THE POSSESSION OF MR. (B)(6)) WHO IS THE SUPPLY CHAIN SPE

  Patient problems: Fainting; Hyperglycemia

  MAUDE report 6341553 ↗