BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1820526 · Received August 30, 2010

    Report

    Report Number
    2939301-2010-07398
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Report Date
    August 26, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE FAILED TESTING. THE METER WAS FOUND TO HAVE CRACKED/BROKEN DISPLAY. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS A LINE THROUGH DISPLAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE CALCIUM RESULTS FOR AN UNKNOWN NUMBER OF PATIENTS. HE PROVIDED CALCIUM RESULTS FOR 19 PATIENTS, FIVE OF THE RESULTS WERE DISCREPANT AND WERE REPORTED OUTSIDE THE LABORATORY. THE ANALYZER USED FOR TESTING WAS A COBAS INTEGRA 400, SERIAL NUMBER (B)(4). THE INITIAL DISCREPANT CALCIUM RESULTS WERE GENERATED BETWEEN (B)(6) 2010 AND (B)(6) 2010, EXACT DATES FOR INITIAL RESULTS ARE NOT KNOWN. ALL REPEAT TESTING OCCURRED ON (B)(6) 2010. PATIENT 1, INITIAL CALCIUM RESULT WAS 8.5 MG/DL, REPEAT RESULT ON SAME ANALYZER GAVE 9.5 MG/DL. PATIENT 2, INITIAL CALCIUM RESULT WAS 8.6 MG/DL, REPEAT RESULT ON SAME ANALYZER GAVE 9.5 MG/DL. PATIENT 3, INITIAL CALCIUM RESULT WAS 11.0 MG/DL, REPEAT RESULT ON SAME ANALYZER GAVE 10.0 MG/DL. PATIENT 4, INITIAL CALCIUM RESULT WAS 8.4 MG/DL, REPEAT RESULT ON SAME ANALYZER GAVE 9.2 MG/DL. PATIENT 5, INITIAL CALCIUM RESULT WAS 8.7 MG/DL, REPEAT RESULT ON SAME ANALYZER GAVE 9.7 MG/DL. CORRECTED REPORTS WERE SENT FOR THE FIVE PATIENTS. ACCORDING TO THE CUSTOMER, NO PATIENTS WERE TREATED BASED ON ERRONEOUS RESULTS. THE ACCOUNT WAS "A FEW DAYS BEHIND" REPORTING RESULTS AND HE IS CERTAIN NO ACTIONS WOULD HAVE BEEN TAKEN BASED ON THE INITIAL RESULTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS THE CALCIUM REAGENT. HE EXAMINED THE ANALYZER AND VERIFIED PRECISION AND ACCURACY OF THE INSTRUMENT WERE ACCEPTABLE. INTERNAL INVESTIGATIONS REVEALED THE PRESENCE OF PRECIPITATE IN REAGENT 2 (R2) OF THE CALCIUM REAGENT LOT. THE ROOT CAUSE FOR THE PRECIPITATION IS STILL UNDER INVESTIGATION. AN URGENT MEDICAL DEVICE REMOVAL NOTICE WAS MAILED OCTOBER 13, 2010 TO ALL CUSTOMERS TO IMMEDIATELY DISCONTINUE USE OF THE CALCIUM REAGENT LOT. CALCIUM DEVIATIONS OF > 20% ABOVE AND BELOW THE REFERENCE RANGE ARE CONSIDERED CRITICAL. THESE DEVIATIONS COULD LEAD TO NON-DETECTION OF A PATHOLOGICAL STATUS OR MAY LEAD TO UNNECESSARY THERAPEUTIC CONSEQUENCES. THE ERRONEOUS BIAS CAUSED BY THIS ASSAY LOT MAY CAUSE PATIENT SAMPLES WITH CRITICALLY HIGH OR CRITICALLY LOW CALCIUM LEVELS TO HAVE RESULTS THAT APPEAR TO BE IN THE NORMAL RANGE. THESE PATIENTS MAY BE AT HIGH RISK FOR MISDIAGNOSIS OF PATHOLOGICAL CONDITIONS ASSOCIATED WITH ABNORMAL CALCIUM LEVELS. INACCURATELY HIGH CALCIUM VALUES MAY LEAD TO AN INCORRECT DIAGNOSIS DEPENDING ON THE BLOOD CALCIUM LEVEL. IN THE WORST CASE, THE WRONG THERAPY MAY BE INITIATED. SUSPECTED HYPERCALCEMIA WOULD MEAN CONFIRMING THE CALCIUM VALUE QUICKLY, AND TREATMENT WOULD OCCUR ACCORDING TO THE CLINICAL PICTURE. A PATIENT NORMALLY SHOWS OBVIOUS SYMPTOMS IF THE CALCIUM VALUE IS >12 MG/DL. IN THE CASE OF INACCURATELY LOW VALUES, THE CALCIUM VALUE MUST BE INTERPRETED TOGETHER WITH OTHER PARAMETERS (E.G., MAGNESIUM, PHOSPHATE, AND PTH). UNNECESSARY FURTHER EXAMINATION AND BLOOD COLLECTION MAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3038411

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR