BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1611625 · Received February 23, 2010

    Report

    Report Number
    1823260-2010-01169
    Event Type
    Malfunction
    Date Received
    February 23, 2010
    Date of Event
    January 12, 2010
    Report Date
    July 9, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFP
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION CONCERNING THE PATIENT WAS PROVIDED: "AT ADMISSION TO THE ER, THE PATIENT WAS ON METFORMIN 1000 MG BID, ATORVASTATIN 10 MG DAILY, ASA 325 MG DAILY, IRBESARTAN 150 MG DAILY, TYLENOL#3 WHEN NEEDED, SYMBICORT 200/6 INHALER AS NEEDED." THE PATIENT RECEIVED CHEMOTHERAPY FOR HIS MYELOMA, BUT NO SPECIFIC INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE WAS NOT IDENTIFED. NO PROBLEMS WERE FOUND WITH CALIBRATION, QUALITY CONTROL, AND PRECISION RECOVERY. POSSIBLE CAUSES FOR THE EVENT INCLUDE SAMPLE OR REAGENT NEEDLE PIPETTING ERROR, PRE- ANALYTICAL SAMPLE HANDLING, AND SAMPLE CONTAMINATION.

    Description of Event or Problem · 1

    THE USER RECEIVED A DISCREPANT CALCIUM RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 2.68 MG/DL AND WAS REPORTED. ON (B)(6) 2010, A REQUEST TO REPEAT THE CALCIUM ASSAY ON THE SAME SAMPLE WAS SENT AND RESULTS OF 4.38 AND 4.47 MG/DL WERE GENERATED ON ANOTHER P MODULE AT THE SITE. THE SAMPLE WAS THEN REPEATED ON THE ORIGINAL ANALYZER AND RESULTS OF 4.23 AND 4.38 MG/DL WERE GENERATED. THE PATIENT RECEIVED TREATMENT FOR HYPOCALCAEMIA. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE PATIENT WAS ADVERSELY AFFECTED. THE CALCIUM REAGENT LOT WAS 617260. IT WAS DETERMINED THE SST SERUM SAMPLE TUBE WAS CENTRIFUGED FOR 7 MINUTES AT 3000 RPMS AT 20 DEGREES C WHICH WAS NOT IN ACCORDANCE WITH THE TUBE MANUFACTURER'S SPECIFICATION.

    Description of Event or Problem · 1

    THE USER RECEIVED A DISCREPANT CALCIUM RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 2.68 MG/DL AND WAS REPORTED. ON (B) (6) 2010, A REQUEST TO REPEAT THE CALCIUM ASSAY ON THE SAME SAMPLE WAS SENT AND RESULTS OF 4.38 AND 4.47 MG/DL WERE GENERATED ON ANOTHER P MODULE AT THE SITE. THE SAMPLE WAS THEN REPEATED ON THE ORIGINAL ANALYZER AND RESULTS OF 4.23 AND 4.38 MG/DL WERE GENERATED. THE PATIENT RECEIVED TREATMENT FOR HYPOCALCAEMIA. NO INFORMATION WAS PROVIDED TO DETERMINE IF THE PATIENT WAS ADVERSELY AFFECTED. THE CALCIUM REAGENT LOT WAS 617260. IT WAS DETERMINED THE SST SERUM SAMPLE TUBE WAS CENTRIFUGED FOR 7 MINUTES AT 3000 RPMS AT 20 DEGREES C WHICH WAS NOT IN ACCORDANCE WITH THE TUBE MANUFACTURER'S SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH THEIR METER. UPON INVESTIGATION, THE METER WAS FOUND TO EXHIBIT THE MEMORY OVERWRITE MALFUNCTION. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINCAL CHEMISTRY ANALYZER JFP ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1