BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® INFORM II METER

    MDR report key: 4031298 · Received August 22, 2014

    Report

    Report Number
    1823260-2014-06427
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    July 23, 2014
    Report Date
    August 22, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K012210
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THE SYSTEM FOR RECORDING PATIENT'S WEIGHT IS RESTRICTED TO WHOLE KILOGRAMS OR POUNDS. THE PATIENT'S WEIGHT WAS 330 GRAMS. CONCOMITANT MEDICATION: DOPAMINE, DOBUTAMINE AND EPINEPHRINE WERE IN A NS BASE.

    Description of Event or Problem · 1

    AN INFORM II SYSTEM USER FACILITY REPORTED THE DEATH OF A NEONATE. THE PATIENT INVOLVED WAS AN EXTREMELY LOW BIRTH WEIGHT PREMATURE NEONATE WEIGHING (B)(6). ESTIMATED GESTATIONAL AGE WAS (B)(6). AT BIRTH ON (B)(6), THE PATIENT WAS DEEMED TO BE IN EXTREMELY CRITICAL CONDITION AND WAS MOVED TO THE INTENSIVE CARE UNIT. WHILE THERE, AN INFORM II METER USED TO TEST THE INFANT DISPLAYED, "GLUCOSE ERROR (E-1503: EXTREMELY HIGH BG RESULT OR ERROR DETECTED DURING TESTING. REPEAT THE TEST USING A NEW STRIP OR VERIFY SYMPTOMS.)" AT 16:13, 16:14 AND 17:04 ON (B)(6). THE ERROR MESSAGE WAS MISINTERPRETED AS INDICATING A VERY HIGH GLUCOSE AND THE NEONATE WAS PLACED ON AN INSULIN INFUSION AT 17:20. A LABORATORY GLUCOSE VALUE OF 6 MG/DL WAS REPORTED AT 21:12 ON (B)(6) AND AN INFORM II RESULT OF 55 MG/DL AT 22:15 ON (B)(6). THE REPORT STATES THAT THE INSULIN INFUSION WAS CONTINUED UNTIL A PERFORMA SYSTEM GLUCOSE VALUE AT AN UNDETERMINED TIME THE MORNING OF (B)(6) REVEALED A GLUCOSE VALUE OF 19 MG/DL. UPON DETERMINING THE INFANT'S BLOOD GLUCOSE WAS LOW, THEY STOPPED INJECTION OF INSULIN AND STARTED TO INJECT DEXTROSE. THE EXACT TIME THE INSULIN INFUSION WAS STOPPED IS NOT CLEAR. IT WAS NOT CLEAR THE AMOUNT OF DEXTROSE ADMINISTERED NOR THE TIME OF ADMINISTRATION. TREATMENT WAS CHANGED (B)(6) 2014, BUT THE BABY EVENTUALLY DIED MORNING (B)(6) 2014. THE CAUSE OF DEATH WAS CONFIRMED BABY'S ATTENDING PHYSICIAN AND A DEATH CERTIFICATE WAS ISSUED STATING "MULTIPLE ORGAN FAILURE AND SEPTIC SHOCK COMING FROM UNCONTROLLABLE HYPOTENSION." INFORM II TESTS (B)(6) 2014: 01:01 E-1503 05:36 E-1503 09:13 E-1503 15:13 E-1503 23:06 E-1503 23:11 E-1503 INFORM II TESTS (B)(6) 2014: 01:31 E-1503 06:20 50 MG/DL (INFORM II RESULTS) 07:12 103 MG/DL (INFORM II RESULTS) THE METER AND STRIPS WERE RETURNED AND INVESTIGATED BY THE MANUFACTURER'S INVESTIGATIVE UNIT. THE TESTING SUMMARY REPORTED NO MALFUNCTIONS AND STATES THE PRODUCTS MET ALL PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509654 ACCU-CHEK ® INFORM II METER BLOOD GLUCOSE MONITORING DEVICE NBW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 001 DA Life Threatening| R DOPAMINE 5MCG/KG/MIN| EPINEPHRINE 0.1 MCG/KG/MIN| DOBUTAMINE 5MCG/KG/MIN| BIOVAN 0.3CC+DW 0.33CC