BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 4792354 · Received May 22, 2015

    Report

    Report Number
    3005862821-2015-00004
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    March 4, 2015
    Report Date
    March 23, 2015
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT METER OPERATED WITHIN SPECIFICATIONS. THE STANDBY CURRENT TEST IS 1.6UA. THE CRITERIA IS LESS THAN 5UA. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. (B)(6) RETURNED HIS STRIP TO PDC/OKB (LOT NUMBER D130524-1), INSIDE THE BOTTLE ONLY LEFT 1 STRIP. OKE CHECKED THE RETAINED STRIPS OF THAT BATCH (D130524-1) IN HOUSE WITH CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 62/64 MG/DL; FOR LEVEL HIGH WERE 269/274 MG/DL. THE CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~75 MG/DL; LEVEL HIGH 220~320 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. OKB ALSO TOOK ANOTHER BATCH OF STRIP (D150316-1) TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION. THE CONTROL SOLUTION TESTS FOR LEVEL LOW ARE 52/51 MG/DL; FOR LEVEL HIGH ARE 289/277 MG/DL. THE CONTROL SOLUTION RANGES ARE: LEVEL LOW 25~70 MG/DL; LEVEL HIGH 210~310 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS.

    Description of Event or Problem · 1

    PDC RECEIVED A CALL ON (B)(6) 2015 REPORTING MEDICAL INTERVENTIONS THAT OCCURRED ON (B)(6) 2015 AND (B)(6) 2015. PT ((B)(6)) COULD NOT RECALL THE ACTUAL TIMES OF EITHER MEDICAL EVENT. ON (B)(6) 2015 PT'S HUSBAND FOUND HER ON THE FLOOR AND UNCONSCIOUS. PRODIGY METER WAS USED BEFORE THE INCIDENT TO CHECK PT'S BLOOD GLUCOSE WITH A RESULT OF 96MG/DL. EMS WERE CALLED AND UPON ARRIVAL TESTED PT'S BLOOD GLUCOSE WITH THEIR METER WITH A RESULT OF 36MG/DL. APPROXIMATELY 10 MINUTES ELAPSED BETWEEN TESTING WITH THE PRODIGY METER AND EMS'S METER. EMS TREATED PT WITH A D50 IV. ON (B)(6) /2015 PT'S HUSBAND WAS AWAKENED BY PT'S SCREAM. HUSBAND WENT TO FIND PT UNCONSCIOUS. HUSBAND THOUGHT PT WAS HAVING A SEIZURE AND CALLED EMS. PRODIGY METER WAS USED BEFORE THE EVENT TO CHECK PT'S BLOOD GLUCOSE WITH A RESULT OF 94MG/DL. PT'S BLOOD GLUCOSE WAS TESTED BY EMS WITH THEIR METER UPON ARRIVAL, WITH A RESULT OF 39MG/DL. NO ELAPSED TIME WAS GIVEN BETWEEN TESTING WITH THE PRODIGY METER AND EMS'S METER. EMS STARTED A IV. PT WAS TRANSPORTED TO ER FOR BOTH EVENTS. ON BOTH TRIPS TO THE ER PT WAS TREATED WITH A D50 IV. PT'S GLUCOSE READING PRIOR TO DISCHARGE WAS 148MG/DL ON (B)(6) 2015. ON (B)(6) 2015 PT WAS NOT SURE BUT BELIEVES THAT HER GLUCOSE READING WAS AROUND 150MG/DL. PT'S STAY AT ER WAS 6-7 HOURS ON (B)(6) 2015 AND 3-4 HOURS ON (B)(6) 2015. PDC SENT REPLACEMENT AND PREPAID ENVELOPE REQUESTING RETURN OF SUSPECT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336127 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D130524-1

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention OMEPRAZOLE 40MG X1| TORSEMIDE 20MG X1| VITAMIN E| KLOR-CON 20MG| EPIPEN| DILTIAZEM 60MG X1 NIGHT| CHROMIUM PICOLINATE 200 MICRO GRAMS| SIGNULAIR 1MG AT NIGHT| LANTIS X2 BY PEN| LEVALBUTEROL 0.63MG/3ML| B COMPLEX| BUDESONIDE/SYMBICORT INHALER| DILTIAZEM 30MG X1 MORNING| DOCUSATE SODIUM 100MG| OXYCODONE SEVERAL TIMES A DAY| LYRICA 200MG X3| CARAFATE X2| MULTIVITAMIN X1| ALBUTEROL 90MCG/INHALER| NOVALOG SHORT ACTING INSULIN X4| MAGNESIUM CHLORIDE 71 1/2M X4