BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 2774720 · Received October 5, 2012

    Report

    Report Number
    1823260-2012-04982
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 25, 2012
    Report Date
    October 5, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER DISCOVERED QUESTIONABLE ION SPECIFIC ELECTRODE (ISE) RESULTS FOR APPROXIMATELY 80 PATIENT SAMPLES WHEN THE RESULTS WERE QUESTIONED BY DOCTORS. THE CUSTOMER STOPPED THE ANALYZER, PERFORMANCE GENERAL MAINTENANCE AND PROBE CLEANING THEN REPLACED THE INTERNAL STANDARD REAGENT. THE CUSTOMER THEN CALIBRATED AND RAN CONTROLS. THE CALIBRATION WAS SUCCESSFUL AND CONTROLS WERE WITHIN SPECIFICATIONS. THE PATIENT SAMPLES WERE THEN REPEATED. OF THE DATA PROVIDED, THE FOLLOWING RESULTS WERE DISCREPANT. ALL RESULTS ARE INITIAL /REPEAT AND ARE IN MMOL/L. PATIENT 1 SODIUM: 126/133. PATIENT 2 SODIUM: 128/139. PATIENT 3 SODIUM: 128/138. PATIENT 4 SODIUM: 139/149. PATIENT 5 SODIUM: 131/139. PATIENT 6 SODIUM: 129/138. PATIENT 7 SODIUM: 125/131. PATIENT 8 SODIUM: 130/137. PATIENT 9 SODIUM: 133/142. PATIENT 10 SODIUM: 129/135. PATIENT 11 SODIUM: 126/135. PATIENT 12 SODIUM: 127/136. PATIENT 13 SODIUM: 129/137. PATIENT 14 SODIUM: 130/ 138. PATIENT 15 SODIUM: 126/134. PATIENT 16 SODIUM: 132/139. PATIENT 17 SODIUM:134/142. PATIENT 18 SODIUM: 131/139. PATIENT 19 SODIUM: 129/137. PATIENT 20 SODIUM: 130/136. PATIENT 21 SODIUM: 131/141. PATIENT 22 SODIUM: 128/137. PATIENT 23 SODIUM: 126/133. PATIENT 24 SODIUM: 128/136. PATIENT 25 SODIUM: 134/141. PATIENT 26 SODIUM: 127/138. PATIENT 27 SODIUM: 131/139. PATIENT 28 SODIUM: 129/137. PATIENT 29 SODIUM: 131/140. PATIENT 30 SODIUM: 131/140. PATIENT 31 SODIUM: 131/139. PATIENT 32 SODIUM: 131/139. PATIENT 33 SODIUM: 129/139. PATIENT 34 SODIUM: 131/139. PATIENT 35 SODIUM: 122/130. PATIENT 36 SODIUM: 132/142. PATIENT 37 SODIUM: 132/140. PATIENT 38 SODIUM: 125/133. PATIENT 39 SODIUM: 127/135. PATIENT 40 SODIUM: 130/141. PATIENT 41 SODIUM: 127/135. PATIENT 42 SODIUM: 130/137. PATIENT 43 SODIUM: 129/138. PATIENT 44 SODIUM: 132/140. PATIENT 45 SODIUM: 118/125. PATIENT 46 SODIUM: 132/140. PATIENT 47 SODIUM: 127/135. PATIENT 48 SODIUM: 124/132. PATIENT 49 SODIUM: 133/140. PATIENT 50 SODIUM: 127/137. PATIENT 51 SODIUM: 130/136. PATIENT 52 SODIUM: 128/138. PATIENT 53 POTASSIUM: 4.2/4.7. PATIENT 54 SODIUM: 135/146. PATIENT 55 POTASSIUM: 4.1/4.6 PATIENT 56 SODIUM: 122/129. PATIENT 57 SODIUM: 134/142. PATIENT 58 SODIUM: 128/135. PATIENT 59 SODIUM: 133/141. PATIENT 60 SODIUM: 123/131. PATIENT 61 SODIUM: 125/136. PATIENT 62 SODIUM: 129/138. PATIENT 63 SODIUM: 132/140. PATIENT 64 SODIUM: 129/138. PATIENT 65 SODIUM: 117/127. PATIENT 66 SODIUM: 133/141. PATIENT 67 SODIUM: 136/142. PATIENT 68 SODIUM: 137/143. PATIENT 69 SODIUM: 131/138. PATIENT 70 SODIUM: 132/143. PATIENT 71 SODIUM: 127/135. PATIENT 72 SODIUM: 125/133. PATIENT 73 SODIUM: 130/138. PATIENT 74 SODIUM: 137/146. PATIENT 75 SODIUM: 132/141. PATIENT 76 SODIUM: 131/140. THE INITIAL RESULTS HAD BEEN REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT AND CORRECTIVE REPORTS WERE SENT. THE CUSTOMER STATED SHE HAD NO KNOWLEDGE OF PATIENT INVOLVEMENT AND HAD NO ACCESS TO PATIENT INFORMATION. THE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE. HE CHECKED THE ISE SYSTEM AND FOUND IT WAS WORKING WHEN HE ARRIVED ON SIGHT AFTER CUSTOMER INTERNAL STANDARD REAGENT AND PERFORMED PROBE CLEANING. THE CUSTOMER'S ISE QC WAS WITHIN THEIR ACCEPTABLE RANGES. HE ALSO RAN PRECIOUS TESTING. THE FIELD APPLICATION SPECIALIST DETERMINED THERE WAS A CALIBRATION ISSUE, POSSIBLY DUE TO EVAPORATION OF STANDARDS. SHE REVIEWED THE CALIBRATION AND QC DATA AND REVIEWED THE ALARM TRACE. SHE DISCUSSED WITH THE CUSTOMER THE IMPORTANCE OF POURING FRESH CALIBRATORS AND QC IMMEDIATELY PRIOR TO CALIBRATING. THE CUSTOMER UNDERSTOOD THE NEED TO POUR FRESH CALIBRATORS AND QC IMMEDIATELY PRIOR TO CALIBRATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER JGS ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1