BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIFA HEPARIN/PF4 RAPID ASSAY

    MDR report key: 9166290 · Received October 8, 2019

    Report

    Report Number
    2247413-2019-00001
    Event Type
    Injury
    Date Received
    October 8, 2019
    Manufacturer
    AKERS BIOSCIENCES, INC.
    Product Code
    LCO
    PMA / PMN Number
    K040293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MW5087039 WAS REPORTED TO MEDWATCH ON (B)(6) 2019. WE RECEIVED IT ON JUNE 12, 2019 AND BEGAN TRYING TO CONTACT THE REPORTER STARTING ON (B)(4) 2019. ON (B)(4) 2019, AFTER 2 ATTEMPTS,WE FINALLY SPOKE WITH DR (B)(6) WHO REPORTED THAT BOTH MW5087039 & MW5087059 MEDWATCH REPORTS WERE REPORTED BY HER ON THE SAME DAY. EACH REPORT WAS ABOUT A SEPARATE INCIDENT & SHE REPORTED THEM BECAUSE SHE "JUST DIDN'T WANT TO HAVE ANY HIPPA VIOLATIONS AND THAT WE SHOULD REALLY TALK TO THE LAB BECAUSE THEY ARE KNOWLEDGEABLE ABOUT THESE THINGS AND SHE WAS ON LEAVE AT THE TIME".THE DR. DECLINED TO GIVE US ANY CONTACT INFORMATION FOR THE LAB EXCEPT THE LOCATION. WE ATTEMPTED CONTACT WITH THE FACILITY 6 TIMES FROM (B)(4) - (B)(4) 2019. WE SPOKE WITH SEVERAL STAFF MEMBERS AT (B)(6) MEDICAL CENTER ON (B)(6) 2019. THEY WERE RELUCTANT TO GIVE OUT ANY INFORMATION BECAUSE THEY DID NOT WANT TO VIOLATE HIPPA REGULATIONS. WHEN ASKED IF A PATIENT HAD BEEN HARMED OR DIED THEY SAID THAT THEY COULD NOT ANSWER THAT. WHEN ASKED FOR DATES THAT THE INCIDENT HAPPENED THEY COULD NOT ANSWER THAT EXCEPT THAT IT HAD OCCURRED IN THE MONTH OF (B)(6) 2018. THEY SAID THEY WOULD FORWARD ANY INFO THEY HAD BUT DID NOT THINK THEY COULD GIVE US A LOT OF INFORMATION BECAUSE OF HIPPA REGULATIONS. WE WERE NEVER CONTACTED BY THE FACILITY OR THE DOCTOR TO REPORT AN INCIDENT OR TO ASK FOR TECHNICAL SUPPORT DURING 2018 OR 2019. WE RECEIVED INFORMATION 7/26/2019 SUGGESTING INJURY TO A PATIENT, PROMPTING THIS REPORT.

    Description of Event or Problem · 1

    AS THE MANUFACTURER, OUR QUALITY DEPARTMENT ATTEMPTED TO CONTACT BOTH THE INITIAL REPORTER AND THE END USER FACILITY. AFTER SEVERAL ATTEMPTS WE WERE ABLE TO CONTACT EACH OF THEM BUT WERE NOT ABLE TO GATHER MUCH INFORMATION ABOUT THE ADVERSE EVENT. BOTH THE INITIAL REPORTER AND THE END USER FACILITY STATED HIPPA AS THE REASON THEY WOULD NOT DISCUSS THE ADVERSE EVENT. SUBSEQUENT TO THIS OUR COMPANY WAS ADVISED THROUGH LEGAL COUNSEL THAT A FEMALE PATIENT HAD A FOOT OR LOWER LEFT LEG AMPUTATED AFTER A KNEE REPLACEMENT SURGERY.

    Description of Event or Problem · 1

    UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961275 PIFA HEPARIN/PF4 RAPID ASSAY PIFA HEPARIN/PF4 RAPID ASSAY LCO AKERS BIOSCIENCES, INC. 24298

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability