BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLTR INFRARED THERMOMETER #TMP102/PC828

    MDR report key: 11286088 · Received February 4, 2021

    Report

    Report Number
    MW5099251
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Date of Event
    December 6, 2020
    Report Date
    February 3, 2021
    Manufacturer
    SHENZEN PACOM MEDICAL INSTRUMENTS CO., LTD.
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INCORRECT TEMPERATURE READING; FLTR TMP102/PC828 INFRARED THERMOMETER OVER A 6 WEEK PERIOD GAVE CONTINUAL INCONSISTENT AND INCORRECT TEMPERATURE READINGS WHICH RESULTED IN UNNECESSARY TREATMENT FOR FEVER. EARLY(B)(6) 2020 I HAD NON-COVID FLU SYMPTOMS -- NAUSEA, G.I. DISTRESS ANOREXIA, ETC., AND ELEVATED AND INCONSISTENT TEMPERATURE READINGS ON THE FLTR DEVICE. WITHIN 3 WEEKS ALL SYMPTOMS WERE GONE BUT THE FEVERS. I WAS REFERRED TO AN I.D. SPECIALIST FOR EVALUATIONS, SUBJECTED TO MULTIPLE EXAMS AND TESTS AND ALL NEGATIVE BUT INDICATION THAT I HAD A VIRUS, BUT THE FEVER, AS SHOWN BY THE FLTR THERMOMETER, CONTINUED AND THE READINGS CONTINUE TO THIS DAY. I WAS SCHEDULED FOR INVASIVE G.I TESTING WHEN MY PRIMARY CARE MD SUGGESTED I TAKE MY TEMP WITH A MERCURY THERMOMETER, BOTH RECTAL AND ORAL AND DID SO WITHIN MINUTES OF THE FLTR READING, WHICH I HAVE DONE NUMEROUS TIMES IN THE PAST THREE WEEKS. MY MERCURY THERMOMETER READINGS WERE CONSISTENTLY NORMAL AND BELOW WHILE THE FLTR READ BETWEEN 98.8 AND 100.7. THESE READINGS CAUSED MUCH ANXIETY, REFERRAL TO AN I.D. SPECIALIST AND MUCH UNNECESSARY TREATMENT AND TESTING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178757 FLTR INFRARED THERMOMETER #TMP102/PC828 THERMOMETER, ELECTRONIC, CLINICAL FLL SHENZEN PACOM MEDICAL INSTRUMENTS CO., LTD. TMP102/PC828

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other