BEUDAMED
    FDA Adverse Event Death Summary report: N

    (COC/AMP/THC/MTD/MDMA/MOP/PCP/BAR/BZO/TCA)MULTI-DRUG ONE STEP10 DRUG SCREEN TEST

    MDR report key: 14844356 · Received June 28, 2022

    Report

    Report Number
    2027969-2022-00046
    Event Type
    Death
    Date Received
    June 28, 2022
    Date of Event
    May 31, 2022
    Report Date
    July 18, 2022
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DIO
    PMA / PMN Number
    K061718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICES NOT RETURNED. INVESTIGATION CONCLUSION: RETAINED DEVICES FROM THE REPORTED LOT NUMBER WERE TESTED WITH IN-HOUSE DRUG-FREE DONOR URINE SAMPLES. THE RESULTS WERE READ AT 5 MINUTES AND ALL DEVICES YIELDED THE EXPECTED NEGATIVE RESULTS FOR COC. NO FALSE POSITIVE RESULTS WERE OBSERVED DURING IN-HOUSE TESTING. THE CASE DETAILS WERE REVIEWED ALONG WITH THE COMPLAINT HISTORY FOR THE REPORTED ISSUE AND NO INDICATIONS OF A SYSTEMIC ISSUE WERE IDENTIFIED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY RELEVANT NON-CONFORMANCE'S AND FOUND THAT THE LOT MET QUALITY CONTROL SPECIFICATIONS. REVIEW OF THE RISK MANAGEMENT REPORT FOR THIS PRODUCT FOUND THAT THE REPORTED ISSUE IS WITHIN THE RISK PROFILE FOR THIS DEVICE; NO NEW HAZARD HAS BEEN IDENTIFIED. CASE DETAILS INDICATE THE PATIENT WAS TAKING MULTIPLE MEDICATIONS AT THE TIME OF TESTING. PER THE ANALYTICAL SPECIFICITY SECTION OF THE PACKAGE INSERT, LORAZEPAM AND OXAZEPAM ARE DETECTED BY THE BZO ASSAY, AND NOT COC. FUROSEMIDE AND FLUOXETINE ARE NOT DETECTED BY THIS AT A CONCENTRATION OF 100 UG/ML. RAMIPRIL, VITAMIN D, LERCANIDIPINE, BISACODYL, DIPYRONE, LITORVA, AND OMEPRAZOLE HAVE NOT BEEN EVALUATED FOR DETECTION BY THIS DEVICE AND ARE THEREFORE NOT LISTED IN THE NON CROSS-REACTING COMPOUND SECTION OF THE PACKAGE INSERT. A ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION AS THE REPORTED ISSUE WAS NOT REPLICATED DURING TESTING OF RETENTION PRODUCT. HOWEVER, REVIEW OF THE PHOTOS PROVIDED FOUND THAT A FAINT TEST LINE APPEARED TO BE VISIBLE ON SOME OF THE COC TEST STRIPS. PLEASE NOTE, THE SHADE OF COLOR IN THE TEST REGION (T) MAY VARY, BUT IT SHOULD BE CONSIDERED NEGATIVE WHENEVER THERE IS EVEN A FAINT COLORED LINE. COMPLAINTS ARE TRACKED AND TRENDED ON A MONTHLY BASIS. PER THE PACKAGE INSERT: THE MULTI-DRUG ONE STEP SCREEN TEST PANEL (URINE) PROVIDES ONLY A PRELIMINARY ANALYTICAL RESULT. A MORE SPECIFIC CHEMICAL METHOD MUST BE USED TO OBTAIN A CONFIRMED RESULT. GAS CHROMATOGRAPHY/MASS SPECTROMETRY (GC/MS) IS THE PREFERRED CONFIRMATORY METHOD. IT IS POSSIBLE THAT TECHNICAL OR PROCEDURAL ERRORS, AS WELL AS OTHER INTERFERING SUBSTANCES IN THE URINE SPECIMEN MAY CAUSE ERRONEOUS RESULTS. A POSITIVE RESULT INDICATES PRESENCE OF THE DRUG OR ITS METABOLITES BUT DOES NOT INDICATE LEVEL OF INTOXICATION, ADMINISTRATION ROUTE OR CONCENTRATION IN URINE.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA FOR MDR 2027969-2022-00046 IN: UPDATE TO D4: EXPIRATION DATE ADDED. UPDATE TO G2: FOREIGN ADDED. UPDATE TO G4: 510K NUMBER ADDED. CORRECTION FOR G3 ON MDR 2027969-2022-00046 IN: DATE RECEIVED BY MANUFACTURER WAS 06/09/2022, NOT 06/06/2022.

    Description of Event or Problem · 0

    (B)(6) 2022: HOSPITAL STATES THEY WERE UNSURE OF THE RESULT OF A DRUG SCREEN PERFORMED ON A PATIENT WHO WAS OVER 70 WHEN TESTING WITH THE MULTI-DRUG ONE STEP 10 DRUG SCREEN TEST KIT AND WILL PERFORM A RETEST. PICTURE PROVIDED INDICATES A POSITIVE RESULT FOR COC. (B)(6) 2022: A RETEST WAS PERFORMED ON THE SAME KIT AND AN ADDITIONAL FALSE POSITIVE WAS OBTAINED FOR COC. A CONFIRMATORY TEST WAS PERFORMED ON THE BIO-RAD TOX SCREEN AND PROVIDED A NEGATIVE RESULT. UNKNOWN THE TIMING BETWEEN OUR TEST AND THE CONFIRMATORY TEST. ALTHOUGH REQUESTED BY LAB, CONFIRMATORY BLOOD TEST WAS NOT PERFORMED AS IT WAS NOT APPROVED BY MANAGEMENT. BASED ON THE POSITIVE RESULT ON THE RETEST, AN ANTIDOTE WAS PROVIDED TO THE PATIENT. UNABLE TO SPECIFY NAME OR DOSAGE OF THE ANTIDOTE. (B)(6) 2022: AN ADDITIONAL TEST WAS PERFORMED ON THE SAME KIT AND AN ADDITIONAL POSITIVE RESULT WAS OBTAINED. (B)(6) 2022: IT WAS REPORTED BY THE CUSTOMER THAT THE PATIENT PASSED AWAY. FURTHER INFORMATION IS CURRENTLY BEING SOUGHT REGARDING CIRCUMSTANCES AROUND THIS EVENT AND THE RELATIONSHIP BETWEEN THE DEVICE AND THE DEATH EVENT. AFTER THE PATIENT DIED, A LAB TEST WAS PERFORMED AT AN EXTERNAL LABORATORY. (B)(6) 2022: LAB RESULT WAS RECEIVED. A NEGATIVE RESULT WAS OBTAINED. MEDICATIONS: OXAZEPAM 10 MG, FUROSEMIDE 40 MG, RAMIPRIL 2.5 MG, VITAMIN D, LERCANIDIPINE 10 MG, LORAZEPAM 1 MG, BISACODYL 5 MG, DIPYRONE 500 MG, FLUOXETINE 20 MG, LITORVA 40 MG, OMEPRAZOLE 20 MG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705646 (COC/AMP/THC/MTD/MDMA/MOP/PCP/BAR/BZO/TCA)MULTI-DRUG ONE STEP10 DRUG SCREEN TEST DRUG SCREEN DIO ALERE SAN DIEGO, INC. DOA-1104 DOA1042278

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death BISACODYL 5 MG| DIPYRONE 500 MG| FLUOXETINE 20 MG| FUROSEMIDE 40 MG| LERCANIDIPINE 10 MG| LITORVA 40 MG| LORAZEPAM 1 MG| OMEPRAZOLE 20 MG| OXAZEPAM 10 MG| RAMIPRIL 2.5 MG| VITAMIN D