BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM, SINGLE SYSTEM SG

    MDR report key: 2303209 · Received October 21, 2011

    Report

    Report Number
    2122870-2011-04817
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    September 9, 2011
    Report Date
    September 22, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT DEMOGRAPHIC AND DIAGNOSTIC INFORMATION WAS NOT SUPPLIED. NO SAMPLE COLLECTION AND CENTRIFUGATION DATA WAS PROVIDED. QC HAD BEEN RECOVERING WITHIN THE ESTABLISHED RANGES PRIOR TO AND ON THE DAY OF THE EVENT. A SYSTEM CHECK WAS PERFORMED ON (B)(6) 2011. ALL RESULTS WERE WELL WITHIN THE PUBLISHED SPECIFICATIONS. THE CUSTOMER USED ACCESS HBSAG REAGENT (CATALOG NUMBER A24291) LOT 192335. THE CUSTOMER PERFORMED ADDITIONAL TESTING WITH REAGENT LOT 192336, AND OBTAINED NEGATIVE RESULTS. THE CUSTOMER SENT BEC TWO REAGENT PACKS FROM EACH OF THE TWO LOTS AND TWO PATIENT SAMPLES OF THE SIMILAR EVENTS FOR FURTHER INVESTIGATION. BEC CUSTOMER PRODUCT LINE SUPPORT (CPLS) COULD NOT REPRODUCE CUSTOMER'S ISSUE AND COULD NOT DETERMINE A ROOT CAUSE TO THE CUSTOMER'S ISSUE: THE TWO SAMPLES WERE NEGATIVE (0.16 AND 0.17 S/CO) NO MATTER WHICH REAGENT PACK WAS USED. THE INVESTIGATION DID NOT SHOW THAT PUNCTURED PACK FROM LOT 192335 SENT BY CUSTOMER WAS DEFECTIVE. CONCERNING LOT 192336, CPLS OBSERVED CONTAMINATION WITH PUNCTURED PACK SENT BY CUSTOMER BUT THIS CAN NOT EXPLAIN THE ISSUE DESCRIBED BY CUSTOMER. THE FACT THAT SOME SAMPLES WERE IMPACTED AND NOT ALL SAMPLES TEND TO SUGGEST A PRE-ANALYTICAL ISSUE. BEC CPLS WOULD RECOMMEND THEREFORE TO CUSTOMER IN CASE OF SIMILAR ISSUE, TO TRANSFER THE SAMPLE FROM THE ORIGINAL TUBE AND RE-CENTRIFUGED PRIOR TO RE-TEST.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) OF OBTAINING (B)(6) RESULTS FROM ACCESS 2 IMMUNOASSAY SYSTEM FOR THREE PATIENT SAMPLES. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REPEAT TESTING PRODUCED NON-REACTIVE INTERPRETATION. THE CUSTOMER STATED THERE WAS NO DEATH OR PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. NOTE: SIMILAR EVENTS ON (B)(6) 2011 ARE REPORTED IN MEDWATCH #2122870-2011-04816, 2122870-2011-04818, AND 2122870-2011-04819, RESPECTIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM, SINGLE SYSTEM SG ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. ACCESS 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1