BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 7340622 · Received March 15, 2018

    Report

    Report Number
    3005862821-2018-00021
    Event Type
    Injury
    Date Received
    March 15, 2018
    Date of Event
    February 18, 2018
    Report Date
    February 20, 2018
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECTED DEVICE EVALUATED BY OK BIOTECH AND CALCULATED THAT THE METER OPERATED WITHIN SPECIFICATIONS. WE TESTED THE STANDBY CURRENT OF RETURN METER, THE RESULT WAS 0.9A. THE CRITERIA IS <55A. PASS. METER SETTING, AUDIO AND ALL BUTTONS FUNCTION ARE OK. WE TESTED THE SUSPECTED METER WITH IN HOUSE CONTROL SOLUTION AND IN HOUSE STRIPS (STRIP LOT NUMBER: D160526-1). THE CONTROL SOLUTION TESTS FOR LEVEL LOW WERE 61/58 MG/DL, FOR LEVEL HIGH WERE 239/245 MG/DL. THE REQUEST CONTROL SOLUTION RANGES ARE: LEVEL LOW 30~80 MG/DL; LEVEL HIGH 190~300 MG/DL. ALL RESULTS WERE WITHIN THE ACCEPTANCE RANGE. PASS. PATIENT'S STRIP LOT # D151117-1 WAS MANUFACTURED ON 11/17/2015 AND EXPIRED IN NOV. 17, 2017. PATIENT USED EXPIRED STRIPS TO TEST BLOOD WHICH MIGHT CAUSED OR CONTRIBUTED TO ERROR READINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2018 AT 7:00 AM AFTER THE END USER ALLEGED THAT SHE RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE RESULTS FROM HER PRODIGY DIABETES METER. SUBSEQUENTLY IT WAS ALSO DISCOVERED THAT SHE WAS USING EXPIRED TEST STRIPS THAT WERE OPEN PAST 90 DAYS. THE END USER WAS EDUCATED ON THE PROPER USE OF HER TEST STRIPS ONCE THE VIAL HAS BEEN OPENED. THE END USER PERFORMED A BLOOD GLUCOSE TEST WITH HER PRODIGY DIABETES METER AND THE RESULT WAS 531 MG/DL. SHE DID NOT EXPERIENCE ANY SIGNIFICANT SYMPTOMS AND OUT OF CONCERN FOR THE HIGH READING SHE WAS TAKEN TO THE ER. UPON ARRIVAL TO THE ER AN ADDITIONAL BLOOD GLUCOSE TEST WAS TAKEN WITH THE HOSPITALS METER AND THE READING WAS 150 MG/DL. SHE RECEIVED SALINE TO ASSIST IN STABILIZING HER BLOOD GLUCOSE LEVEL. AN X-RAY WAS PERFORMED WHICH REVEALED THAT SHE HAD A CRACKED RIB. AFTER 4 HOURS IN THE ER THE END USER WAS DISCHARGED AND INSTRUCTED TO FOLLOW-UP WITH HER PCP. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185114 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 54800 - D151117-1 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 3 L OXYGEN PER MIN| ALPRAZOLAM .5MG DAILY| AMOXICILLIN 500MG| CALCIUM| DIGOXIN .125 MG DAILY| FIORICET| JANUVIA 50 MG| LASIX 40MG| LOMOTIL 2.5MG AS NEEDED| METOPROLOL 75MG 2X A DAY| MULTIVITAMINS| NITROGLYCERIN .2MG 12 HOURS DAILY| SIMVASTATIN 20MG DAILY| TRAMADOL HCL 550MG| WARFARIN 5MG DAILY