BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLACTIN

    MDR report key: 1893468 · Received November 8, 2010

    Report

    Report Number
    1823260-2010-06629
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 14, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS CORPORATION
    Product Code
    JJE
    PMA / PMN Number
    K930305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED TO DETERMINE THE CORRECT DATE OF THE EVENT WAS (B)(6) 2010. THE CORRECT DATE THE INFORMATION WAS RECEIVED BY THE MANUFACTURER WAS (B)(6) 2010. THE FOLLOWING INFORMATION CONCERNING THE PATIENT TREATMENT WAS PROVIDED. "THE PATIENT WILL UNDERGO A SURGICAL OPERATION ACCORDING TO THE PROLACTIN RESULT." AND "AS AN INPATIENT, HE IS WAITING FOR THE POSSIBLE OPERATION DECISION.". NO FURTHER INFORMATION CONCERNING THE PATIENT TREATMENT COULD BE PROVIDED. NO ADVERSE EVENTS HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION, NO ASSAY ISSUE COULD BE IDENTIFIED. THE OBSERVED RESULTS COULD HAVE A VARIETY OF CAUSES INCLUDING AN INTERFERENCE TO THE ASSAY. HOWEVER AS INSUFFICIENT DATA WAS PROVIDED, FURTHER INVESTIGATION WAS NOT POSSIBLE. A CLEAR ROOT CAUSE REMAINS UNCLEAR. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRASMART METER WAS READING INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE LAY USER/PATIENT ON NOVEMBER 19, 2010 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT TESTS THREE TIMES A DAY AND MANAGES HIS DIABETES WITH A SINGLE DOSE (10MG) OF GLIPIZIDE IN THE MORNING, 1000MG OF METFORMIN IN THE MORNING AND EVENING, AND A SINGLE DOSE (45MG) OF ACTOS IN THE MORNING. THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2010 (TIME UNKNOWN). THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "206,170, AND 128MG/DL" WITH THE SUBJECT METER, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. IN RESPONSE TO THE ALLEGED ISSUE, THE PATIENT CORRECTED AND CLARIFIED THAT HE TOOK AN ADDITIONAL DOSE OF GLIPIZIDE; PRIOR TO THE ALLEGED ISSUE THE PATIENT INDICATED HE HAD ALREADY TAKEN HIS MORNING MEDICATIONS. ACCORDING TO THE PATIENT, WHEN HIS BLOOD GLUCOSE LEVEL IS ELEVATED, HE WAS ADVISED BY HIS PHYSICIAN (IN THE PAST) TO TAKE AN ADDITIONAL DOSE OF GLIPIZIDE. APPROXIMATELY 1 ½ HOURS LATER, THE PATIENT CONFIRMED HE EXPERIENCED SWEATING AND ALSO DID NOT FEEL WELL. AT THE ONSET OF HIS SYMPTOMS, THE PATIENT CLARIFIED HE TESTED HIS BLOOD GLUCOSE (WITH THE SUBJECT METER) AND OBTAINED A RESULT BETWEEN "40 -60 MG/DL". THE PATIENT IMMEDIATELY ADMINISTERED SELF-TREATMENT BY CONSUMING A GLUCOSE TABLET. APPROXIMATELY 1 ½ HOURS LATER, THE PATIENT STATED HE FELT BETTER AND OBTAINED A BLOOD GLUCOSE RESULT OF "82MG/DL" WITH THE SUBJECT METER. THE PATIENT INDICATED HE CONTACTED HIS PHYSICIAN ON (B)(6) 2010 AND THE GLIPIZIDE MEDICATION WAS REMOVED FROM HIS DAILY REGIMEN. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, HE WAS CLEANING THE PUNCTURE AREA PROPERLY, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING (MG/DL), AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S BOOKLET) SAMPLE SITE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMER HE OBTAINED INACCURATE READINGS ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE PROLACTIN RESULT FOR ONE PATIENT SAMPLE. INFORMATION WAS NOT PROVIDED TO DETERMINE WHICH ROCHE ANALYZER PRODUCED THE RESULT. THE INITIAL RESULT WAS 20 NG/ML. THE SAMPLE WAS REPEATED AND A SIMILAR RESULT WAS FOUND. NO SPECIFIC DATA WAS PROVIDED. THE SAMPLE WAS TESTED ON A SIEMENS ANALYZER WITH A 1:5 DILUTION AND A RESULT OF 13.58 NG/ML WAS GENERATED. THE SAMPLE WAS TESTED ON AN ADVIA ANALYZER WITH A 1:100 DILUTION AND A RESULT OF 14.78 NG/ML WAS GENERATED. THE SAMPLE WAS TESTED ON A CENTAUR ANALYZER WITH A 1:100 DILUTION AND A RESULT OF 55 NG/ML WAS GENERATED. THE CLINICIAN FOUND THESE RESULTS INCOMPATIBLE. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE EVENT.

    Description of Event or Problem · 1

    LITERATURE: FAUCHERON JL, VOIRIN D, BADIC B, SACRAL NERVE STIMULATION FOR FECAL INCONTINENCE: CAUSES OF SURGICAL REVISION FROM A SERIES OF 87 CONSECUTIVE PTS OPERATED ON IN A SINGLE INSTITUTION. DIS COLON RECTUM. NOV 2010;53(11): 1501-1507. SUMMARY: THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE CAUSES OF SURGICAL REVISION FOLLOWING SACRAL NERVE STIMULATION IN CONSECUTIVE PTS WHO HAD RECEIVED IMPLANTS. FROM (B)(6) 2001 TO (B)(6) 2009, 123 PTS (105 WOMEN) OF MEAN AGE 56 YRS WERE OPERATED ON FOR NEUROLOGICAL (N=104) OR IDIOPATHIC (N=19) FECAL INCONTINENCE. EIGHTY-SEVEN PTS OF 123 HAD A POSITIVE TEST AND UNDERWENT STIMULATOR IMPLANTATION. ANY STIMULATOR DYSFUNCTION WAS PROSPECTIVELY STUDIED. AMONG THE 87 PTS, 36 HAD SURGICAL REVISION OF THE DEVICE FOR THE FOLLOWING REASONS: DEVICE-RELATED FAILURE DUE TO INFECTION, ELECTRODE DISPLACEMENT OR BREAKAGE, AND DYSFUNCTION OWING TO IMPEDANCE INCREASE OF THE SYSTEM; ADVERSE STIMULATION WITH PAIN; BATTERY DEPLETION EITHER OF GENERATOR END OF LIFE OR MRI; AND LOSS OF CLINICAL EFFICACY. AMONG THE 87 PTS, 21 HAD REMOVAL OF THE STIMULATOR DURING F/U. REPORTABLE EVENT: IT WAS REPORTED THAT ONE PT (A (B)(6) FEMALE) HAD TO BE SURGICALLY EXPLORED BECAUSE THEY PRESENTED WITH SUDDEN WORSENING OF THE FUNCTIONAL RESULTS (RECURRENCE OF ANAL INCONTINENCE ASSOCIATED WITH LIGHTNING PAINS ALONG THE LEG WHEN EXTENDING THE THIGH ON THE SAME SIDE AS THE ELECTRODE IMPLANTATION AND NOT THE STIMULATOR SITE. THE IMPENDENCE OF THE SYSTEM WAS OVER 4000 OHMS BUT THE BATTERY WAS NOT DEPLETED. X-RAY SHOWED A BROKEN ELECTRODE AND THE OPERATION CONFIRMED THAT THE METALLIC WIRE OF THE ELECTRODE WAS BROKEN, DESPITE THAT THE SILICONE SHEATH WAS INTACT. THE SOURCE LITERATURE DID NOT SPECIFY WHICH DEVICE MODELS WERE USED. SEE LITERATURE ARTICLE WITH MFR REPORT# 3007566237-2010-10392.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLACTIN RADIOIMMUNOASSAY,PROLACTIN (LACTOGEN) JJE ROCHE DIAGNOSTICS CORPORATION 158324

    Patients

    Seq Age Sex Outcome Treatment
    1