BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2017-00646

    MDR report key: 6436015 · Received March 27, 2017

    Report

    Report Number
    1823260-2017-00646
    Event Type
    Malfunction
    Date Received
    March 27, 2017
    Date of Event
    February 23, 2017
    Report Date
    March 27, 2017
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED QUESTIONABLE RESULTS FOR ONE PATIENT USING THE ELECSYS PTH IMMUNOASSAY (PTH) ON THE COBAS E 411 IMMUNOASSAY ANALYZER. ALL RESULTS ARE IN UNITS OF PG/ML. ON (B)(6) 2017, THE INITIAL RESULT PRIOR TO SURGERY WAS 128.2. THIS RESULT WAS CONSIDERED THE PATIENT'S BASELINE. THE PATIENT THEN ENTERED SURGERY TO HAVE HIS PARATHYROID GLAND REMOVED. DURING SURGERY, THE PHYSICIAN ORDERED AN INTRA-OPERATIVE PTH RESULT IN ORDER TO DETERMINE IF THE GLAND HAD BEEN REMOVED ENTIRELY AND TO ENSURE THAT NO ADENOMA EXISTED. THE PHYSICIAN EXPECTED THE NEW RESULT TO BE SIGNIFICANTLY LOWER THAN THE BASELINE RESULT. WHILE AWAITING THE INTRA-OPERATIVE RESULT, THE PHYSICIAN CLOSED THE SURGICAL SITE. A NEW SAMPLE WAS TAKEN FROM THE PATIENT. THE INTRA-OPERATIVE RESULT WAS 151.5 AND WAS RELEASED TO THE PHYSICIAN. DUE TO THIS RESULT, THE PATIENT'S SURGICAL SITE IN THE NECK WAS REOPENED TO CHECK FOR REMAINING PARATHYROID TISSUE OR ADENOMA. THE PHYSICIAN EXPLORED THE RIGHT SIDE OF THE THYROID GLAND AND FOUND NO ISSUES. THE PHYSICIAN QUESTIONED THE RESULT. THE ORIGINAL SAMPLE WAS REPEATED WITH RESULTS OF 30.34, 30.69, AND 19.32. THE RESULT OF 19.32 WAS RELEASED TO THE PHYSICIAN, AND THE LABORATORY STAFF STATED THE PREVIOUS RESULT OF 151.5 WAS ERRONEOUS. THE PHYSICIAN THEN PROCEEDED TO CLOSE THE PATIENT'S SURGICAL SITE. THE PATIENT WAS DIAGNOSED WITH PRIMARY HYPERPARATHYROIDISM AFTER THE OPERATION. THE PATIENT WAS STABLE AFTER SURGERY, AND WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY. THE PTH REAGENT LOT NUMBER IS 143261. THE EXPIRATION DATE WAS NOT PROVIDED. THE CUSTOMER STATED THERE WAS NO INTERFERENCE NOR ANY CLOTS IN THE INTRA-OPERATIVE SAMPLE. CALIBRATION AND QC WAS ACCEPTABLE ON THE DATE OF THE EVENT. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED FOR THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. BASED UPON THE AVAILABLE INFORMATION, A GENERAL REAGENT ISSUE AND ELECTROMAGNETIC INFERENCE CAN BE EXCLUDED. POSSIBLE ROOT CAUSES FOR THIS EVENT MAY BE SAMPLE QUALITY, INSUFFICIENT MAINTENANCE, OR CONTAMINATION OF THE ENVIRONMENT WITH THE ANALYTE. IT WAS NOTED THAT THE CUSTOMER CENTRIFUGED THE INTRA-OPERATIVE SAMPLE FOR 4 MINUTES, INSTEAD OF 10 MINUTES, PER THE TUBE MANUFACTURER'S REQUIREMENTS. THIS IS SIGNIFICANTLY LOWER THAN THE REQUIRED CENTRIFUGATION TIME.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR