BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCU-CHEK INFORM II TEST STRIPS

    MDR report key: 16769500 · Received April 19, 2023

    Report

    Report Number
    1823260-2023-01319
    Event Type
    Death
    Date Received
    April 19, 2023
    Date of Event
    March 20, 2023
    Report Date
    December 13, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    UDI-DI
    00365702428102
    PMA / PMN Number
    K121679
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS REVIEWED BY A ROCHE PHYSICIAN WHO STATED THAT THOUGH HYPOGLYCEMIA CAN LEAD TO RAPID DECOMPENSATION, IT CAN ALSO RAPIDLY BE CORRECTED WHEN NEW VALUES ARE OBTAINED. A SEPTIC STATE CAN LEAD TO RAPID FLUCTUATIONS IN BLOOD GLUCOSE DUE TO INCREASED METABOLIC DEMAND FROM THE RESULTING ILLNESS. GENERALLY, A FATAL DOSE OF INSULIN WOULD RAPIDLY LEAD TO SEIZURES, COMA, AND DEATH THAT WOULD TAKE A PERIOD OF MINUTES RATHER THAN HOURS TO RESULT IN DEATH. HOWEVER, GIVEN THE LACK OF DETAILS REGARDING THE TIME COURSE, AT THIS TIME, IT IS NOT POSSIBLE TO EXCLUDE THAT AN ERRONEOUS BLOOD GLUCOSE CONTRIBUTED TO THE PATIENT¿S DETERIORATION IN HEALTH AND ULTIMATELY DEATH HOURS LATER. NO PRODUCT WILL BE RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ON A REGULAR BASIS ACCU-CHEK INFORM STRIPS OF LOTS CURRENTLY VALID IN THE MARKET ARE TESTED AS PART OF ROUTINE RETENTION TESTING AND RESULTS HAVE PASSED THE INTERNAL INSPECTION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED THAT SHE IS CONCERNED THAT THE INFORM II METER DOES NOT DISCUSS ANY LIMITATIONS IN CRITICALLY ILL PATIENTS WITH SEPSIS. DURING THE CALL, IT WAS MENTIONED THAT A PATIENT DIED AT A "DIFFERENT" HOSPITAL APPROXIMATELY 3-4 YEARS AGO FOLLOWING TREATMENT BASED ON A RESULT FROM AN ACCU-CHEK INFORM II METER. THE INITIAL REPORTER WAS UNWILLING TO PROVIDE THE NAME OF THE FACILITY WHERE THE PATIENT DIED. SHE ALSO STATED THAT SHE WAS UNABLE TO REMEMBER THE EXACT DATE OF THE PATIENT¿S DEATH OR THE YEAR. THE OFFICIAL CAUSE OF DEATH WAS REPORTEDLY A URINARY TRACT INFECTION AND SEPSIS. AT THIS TIME THE TIME COURSE OF THESE EVENTS IS UNCLEAR. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT UNRESPONSIVE, WITH A URINARY TRACT INFECTION AND DEHYDRATION REPORTED. THE PATIENT WAS REPORTED TO NOT HAVE ANY URINE OUTPUT INITIALLY PRIOR TO INTRAVENOUS FLUIDS AND ANTIBIOTICS. THE INITIAL REPORTER ALLEGED THAT AFTER A FEW HOURS OF TREATMENT, THE PATIENT BECAME RESPONSIVE, AND WAS TALKING AND SITTING UP IN BED. REPORTEDLY, THE PATIENT HAD A BLOOD GLUCOSE PERFORMED AT THE BEDSIDE ON THE INFORM II METER USING A FINGERSTICK AND THE RESULT WAS REPORTEDLY OVER 500 MG/DL. THE PATIENT WAS SUBSEQUENTLY TREATED WITH INTRAVENOUS INSULIN. AT SOME POINT SURROUNDING THESE EVENTS, LABORATORY GLUCOSE WAS DRAWN, ALTHOUGH THE EXACT TIMING IS UNKNOWN AS THE TEST WAS PERFORMED BEFORE THE INITIAL REPORTER HAD ARRIVED AT THE BEDSIDE. THE RESULT FROM THE LABORATORY VALUE WAS NOT AVAILABLE UNTIL AFTER THE PATIENT HAD ALREADY BEEN TREATED WITH INSULIN BASED ON THE INFORM II METER RESULT. THE LABORATORY RESULT WAS REPORTED TO BE BELOW 100 BUT THE EXACT VALUE IS ALSO UNKNOWN. ALLEGEDLY, A FEW HOURS LATER THE PATIENT PASSED AWAY. THE PRODUCT LABELING LISTS HYPOPERFUSED STATES AS A LIMITATION OF THE DEVICE, "IF PERIPHERAL CIRCULATION IS IMPAIRED, COLLECTION OF CAPILLARY BLOOD FROM THE APPROVED SAMPLE SITES IS NOT ADVISED AS THE RESULTS MIGHT NOT BE A TRUE REFLECTION OF THE PHYSIOLOGICAL BLOOD GLUCOSE LEVEL. THIS MAY APPLY IN THE FOLLOWING CIRCUMSTANCES: SEVERE DEHYDRATION AS A RESULT OF DIABETIC KETOACIDOSIS OR DUE TO HYPERGLYCEMIC HYPEROSMOLAR NON-KETOTIC SYNDROME, HYPOTENSION, SHOCK, DECOMPENSATED HEART FAILURE NYHA CLASS IV, OR PERIPHERAL ARTERIAL OCCLUSIVE DISEASE." PRODUCT LABELING ALSO STATES: THE SYSTEM HAS NOT RECEIVED FDA CLEARANCE FOR USE WITH PATIENTS RECEIVING INTENSIVE MEDICAL INTERVENTION OR THERAPY. ADDITIONAL INFORMATION REQUESTED BUT UNABLE TO BE PROVIDED BY THE INITIAL REPORTER: -THE AMOUNT OF INSULIN GIVEN TO THE PATIENT -WHETHER THE PATIENT RECEIVED ANY INFORMATION ON ANY TREATMENT TO REVERSE THE INSULIN -ANY OTHER DETAILS RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372721 ACCU-CHEK INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU 00365702428102

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Female Death