BEUDAMED
    FDA Adverse Event Summary report: N

    THERASPHERE

    MDR report key: 5959249 · Received September 19, 2016

    Report

    Report Number
    3002124545-2016-00063
    Date Received
    September 19, 2016
    Date of Event
    August 26, 2016
    Report Date
    August 31, 2016
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    NAW
    PMA / PMN Number
    H980006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HIGH DOSE TO ONE AREA WITHIN THE LOBE AND A COLD DOSE WITHIN THE OTHER AREA [RADIATION OVERDOSE]. HIGH DOSE TO ONE AREA WITHIN THE LOBE AND A COLD DOSE WITHIN THE OTHER AREA [RADIATION UNDERDOSE]. NUCLEAR MEDICINE GAVE THE AU THE 9 GBQ WHEN HE NEEDED TO 7 GBQ AND VICE VERSA [DEVICE USE ERROR]. CASE DESCRIPTION: INITIAL INFORMATION WAS RECEIVED ON 31-AUG-2016: THIS SPONTANEOUS MEDICAL DEVICE REPORT WAS RECEIVED FROM A COMPANY REPRESENTATIVE ON BEHALF OF A PHYSICIAN (AUTHORIZED USER) CONCERNING A PATIENT OF UNKNOWN AGE OR GENDER. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE UNKNOWN. THE PATIENT RECEIVED THERASPHERE, (LOT NUMBER AND EXPIRATION DATE UNKNOWN), A 2 DOSE VIAL INFUSION, 9 GBQ AND 7 GBQ, FOR AN UNSPECIFIED INDICATION ON (B)(6) 2016. ON (B)(6) 2016, NUCLEAR MEDICINE GAVE THE AUTHORIZED USER (AU) THE 9 GBQ WHEN HE NEEDED TO 7 GBQ AND VICE VERSA, THIS RESULTED IN A HIGH DOSE TO ONE AREA WITHIN THE LOBE AND A COLD DOSE WITHIN THE OTHER AREA. THERE WERE 2 VIALS, A 9 GBQ AND A 7 GBQ TO BE ADMINISTERED TO THE PATIENT. ON (B)(6) 2016, DURING THE TIME OF ADMINISTRATION, NUCLEAR MEDICINE GAVE THE AUTHORIZED USER (AU) THE 9 GBQ WHEN HE NEEDED TO 7 GBQ AND VICE VERSA, THIS RESULTED IN A HIGH DOSE TO ONE AREA WITHIN THE LOBE AND A COLD DOSE WITHIN THE OTHER AREA. ON AN UNSPECIFIED DATE IN (B)(6) 2016, A POST ADMINISTRATION PET OR SPECT CT SHOWED THE ORIGINAL AREA THAT WAS THOUGHT TO BE UNDER TREATED WAS ACTUALLY TREATED APPROPRIATELY. THE TREATMENT FOR AND THE OUTCOME OF THE EVENTS IS UNKNOWN. THE REPORTING PHYSICIAN DID NOT ASSESS THE SERIOUSNESS THE HIGH DOSE TO ONE AREA WITHIN THE LOBE AND A COLD DOSE WITHIN THE OTHER AREA. THE COMPANY CONSIDERS THE RADIATION OVERDOSE AND RADIATION UNDERDOSE TO BE SERIOUS (MEDICALLY SIGNIFICANT). FOLLOW-UP INFORMATION WILL BE REQUESTED. COMPANY COMMENT: THE RADIATION OVERDOSE AND RADIATION UNDERDOSE AND DEVICE USE ERROR ARE CONSIDERED TO BE UNLISTED ACCORDING TO CURRENT THERASPHERE CURRENT REFERENCE SAFETY INFORMATION. THE COMPANY CONSIDERS THAT RADIATION OVERDOSE AND RADIATION UNDERDOSE AND DEVICE USE ERROR ARE NOT ADVERSE EVENTS PER SE BUT SPECIAL SCENARIOS AND THEREFORE NOT ASSESSABLE. OVERDOSE TO ONE TREATMENT AREA AND UNDERDOSE TO THE OTHER DUE TO WRONG DOSES GIVEN. NO ADVERSE EVENT REPORTED. POTENTIAL FOR HARM POSSIBLE AS UNDERTREATMENT AND OVERDOSAGE TO TUMOUR. THIS SINGLE CASE REPORT DOES NOT MODIFY THE RISK BENEFIT BALANCE OF THERASPHERE. THE COMPANY IS CONTINUOUSLY MONITORING ALL RESPECTIVE REPORTS RECEIVED AND, BASED ON CUMULATIVE EXPERIENCE, WILL RE-EVALUATE THE AVAILABLE EVIDENCE ON AN ONGOING BASIS.

    Description of Event or Problem · 1

    HIGH DOSE TO ONE AREA WITHIN THE LOBE AND A COLD DOSE WITHIN THE OTHER AREA [RADIATION OVERDOSE]. HIGH DOSE TO ONE AREA WITHIN THE LOBE AND A COLD DOSE WITHIN THE OTHER AREA [RADIATION UNDERDOSE]. NUCLEAR MEDICINE GAVE THE AU THE 9 GBQ WHEN HE NEEDED TO 7 GBQ AND VICE VERSA [DEVICE USE ERROR] . CASE DESCRIPTION: INITIAL INFORMATION WAS RECEIVED ON 31-AUG-2016: THIS SPONTANEOUS MEDICAL DEVICE REPORT WAS RECEIVED FROM A COMPANY REPRESENTATIVE ON BEHALF OF A PHYSICIAN (AUTHORIZED USER) CONCERNING A PATIENT OF UNKNOWN AGE OR GENDER. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE UNKNOWN. THE PATIENT RECEIVED THERASPHERE, (LOT NUMBER AND EXPIRATION DATE UNKNOWN), A 2 DOSE VIAL INFUSION, 9 GBQ AND 7 GBQ, FOR AN UNSPECIFIED INDICATION ON (B)(6) 2016. ON (B)(6) 2016, NUCLEAR MEDICINE GAVE THE AUTHORIZED USER (AU) THE 9 GBQ WHEN HE NEEDED TO 7 GBQ AND VICE VERSA, THIS RESULTED IN A HIGH DOSE TO ONE AREA WITHIN THE LOBE AND A COLD DOSE WITHIN THE OTHER AREA. THERE WERE 2 VIALS, A 9 GBQ AND A 7 GBQ TO BE ADMINISTERED TO THE PATIENT. ON (B)(6) 2016, DURING THE TIME OF ADMINISTRATION, NUCLEAR MEDICINE GAVE THE AUTHORIZED USER (AU) THE 9 GBQ WHEN HE NEEDED TO 7 GBQ AND VICE VERSA, THIS RESULTED IN A HIGH DOSE TO ONE AREA WITHIN THE LOBE AND A COLD DOSE WITHIN THE OTHER AREA. ON AN UNSPECIFIED DATE IN (B)(6) 2016, A POST ADMINISTRATION PET OR SPECT CT SHOWED THE ORIGINAL AREA THAT WAS THOUGHT TO BE UNDER TREATED WAS ACTUALLY TREATED APPROPRIATELY. THE TREATMENT FOR AND THE OUTCOME OF THE EVENTS IS UNKNOWN. THE REPORTING PHYSICIAN DID NOT ASSESS THE SERIOUSNESS THE HIGH DOSE TO ONE AREA WITHIN THE LOBE AND A COLD DOSE WITHIN THE OTHER AREA. THE COMPANY CONSIDERS THE RADIATION OVERDOSE AND RADIATION UNDERDOSE TO BE SERIOUS (MEDICALLY SIGNIFICANT). FOLLOW-UP INFORMATION WILL BE REQUESTED. FOLLOW-UP INFORMATION WAS RECEIVED FROM AN OTHER NON-HEALTH CARE PROFESSIONAL ON 28-SEP-2016: THE PATIENT DEMOGRAPHICS WERE UPDATED. THE PATIENT WAS A (B)(6) MALE AT THE TIME OF THE EVENT. THE PATIENT'S MEDICAL HISTORY INCLUDED COLORECTAL CANCER WITH METASTASES. THE INDICATION FOR TREATMENT WITH THERASPHERE WAS COLORECTAL CANCER WITH METASTASES. THE PATIENT WAS TREATED WITH VIAL NUMBERS 34 AND 35 WITH EXPIRATION DATES OF 02-SEP-2016. AS OF THE TIME OF THIS REPORT, THE PATIENT DID NOT EXPERIENCE ANY COMPLICATIONS AS A RESULT OF THE HIGH DOSE TO ONE AREA WITHIN THE LOBE AND A COLD DOSE WITHIN THE OTHER AREA. THE COMPANY HAS DOWNGRADED THE RADIATION UNDERDOSE TO NON-SERIOUS. FURTHER FOLLOW-UP WILL BE REQUESTED. COMPANY COMMENT: THE RADIATION OVERDOSE, RADIATION UNDERDOSE AND DEVICE USE ERROR ARE CONSIDERED TO BE UNLISTED ACCORDING TO CURRENT THERASPHERE CURRENT REFERENCE SAFETY INFORMATION. THE COMPANY CONSIDERS THAT RADIATION OVERDOSE, RADIATION UNDERDOSE AND DEVICE USE ERROR ARE NOT ADVERSE EVENTS PER SE BUT SPECIAL SCENARIOS AND THEREFORE NOT ASSESSABLE. OVERDOSE TO ONE TREATMENT AREA AND UNDERDOSE TO THE OTHER DUE TO WRONG DOSES GIVEN. NO ADVERSE EVENT REPORTED. POTENTIAL FOR HARM POSSIBLE AS UNDERTREATMENT AND OVERDOSAGE TO TUMOUR. THIS SINGLE CASE REPORT DOES NOT MODIFY THE RISK BENEFIT BALANCE OF THERASPHERE. THE COMPANY IS CONTINUOUSLY MONITORING ALL RESPECTIVE REPORTS RECEIVED AND, BASED ON CUMULATIVE EXPERIENCE, WILL RE-EVALUATE THE AVAILABLE EVIDENCE ON AN ONGOING BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610715 THERASPHERE SINGLE USE IMPLANTABLE MEDICAL DEVICE NAW BIOCOMPATIBLES UK LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| S