BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLTR

    MDR report key: 11586900 · Received March 29, 2021

    Report

    Report Number
    3013147512-2021-00001
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    December 6, 2020
    Report Date
    February 3, 2021
    Manufacturer
    SHENZHEN PACOM MEDICAL INSTRUMENTS CO., LTD.
    Product Code
    FLL
    PMA / PMN Number
    K172889
    Removal / Correction Number
    MW5099251
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER EMAIL COMMUNICATION, THE PATIENT (B)(6) TOLD THAT THE PC828 INFRERED THERMOMETER SOMETIMES (NOT ALWAYS) DID NOT REPORT HER TEMPERATURE CORRECTLY DURING USING, BUT IT IS NOT NECESSARY FOR HER TO HAVE A REPLACEMENT. SO, WE THINK SHE HAS MASTERED THE REQUIREMENTS AND METHODS FOR THE CORRECT USE OF OUR INFRARED THERMOMETER. (B)(6). (B)(6) 2021.

    Description of Event or Problem · 0

    THE INITIAL REPORT DESCRIPTIONS AS BELOW: WE RECEIVED A NOTIFICATION LETTER OF PATIENT COMPLAINT AND FORWARDED BY MDR TEAM OF FDA ON FEB. 25, 2021. THE REPORT NUMBER IS MW5099251, WE SAW THAT THE PATIENT (B)(6) DECLARED SHE GOT MUCH ANXIETY AND DID MUCH UNNECESSARY TREATMENT AND TESTING DURING USING OUR PRODUCT- INFRARED THERMOMETER PC828. AS HER DESCRIPTION, WHEN SHE JUST RECOVERED FROM A NON-COVID FLU SYMPTOMS, PC828 STILL CONTINUAL GAVE HER INCONSISTENT AND INCORRECT TEMPERATURE READINGS ABOUT 3 WEEKS, WHICH CAUSED HER TO CONSULT A PRIMARY CARE MD AND CONDUCT MORE TESTS WITH MERCURY THERMOMETER. BASED ON THE ABOVE PROBLEM, WE HAVE EMAILED AND PHONED (B)(6) FOR THE FIRST TIME. IN THE EMAIL, WE TALKED ABOUT THE RECALL UNIT FOR HER TO DO FURTHER RESEARCH, INVESTIGATE IF THE PRODUCT FAILURES AND WHAT HAPPENED. MEANWHILE, WE BRIEFLY ILLUSTRATED TO (B)(6) ABOUT HOW TO USE INFRARED THERMOMETER CORRECTLY AND INTRODUCE CHARACTERISTICS OF FEVER ALERT OF OUR PRODUCT PC828, WE SUPPOSE THAT 2 SITUATIONS MAY EXIST: PRODUCT MALFUNCTION OR THE USING METHOD IS NOT CORRECT. WE ARE EXPECTING THAT (B)(6) CAN COOPERATE WITH US TO COUNTERCHECK THE PC828 ACCORDING TO THE CORRECT USING METHOD AND IN A SUITABLE ENVIRONMENT REQUIREMENT, BUT (B)(6) INSISTED ON PRODUCT MALFUNCTION. SO WE HAVE INFORMED (B)(6) TO SEND BACK THE PRODUCT FREELY FOR INVESTIGATION AND SHE AGREED. WE WILL SEND HER A NEW ONE. CURRENTLY, WE ARE WAITING FOR (B)(6) NEXT ACTION. (B)(6). (B)(6) 2021. THE NEW UPDATED INFORMATION: AFTER EMAIL COMMUNICATION, THE PATIENT (B)(6) TOLD THAT HER PC828 INFRARED THERMOMETER IS SOMETIMES (NOT ALWAYS) DID NOT REPORT HER TEMPERATURE CORRECTLY. IT IS NOT NECESSARY FOR HER TO HAVE A REPLACEMENT THERMOMETER. SO, WE THINK THE PATIENT HAS MASTERED THE REQUIREMENTS AND METHODS FOR THE CORRECT USE OF OUR INFRARED THERMOMETER. (B)(6). (B)(6) 2021.

    Description of Event or Problem · 1

    WE RECEIVED A NOTIFICATION LETTER OF PATIENT COMPLAINT AND FORWARDED BY MDR TEAM OF FDA ON FEB. 25, 2021. THE REPORT NUMBER IS MW5099251, WE SAW THAT THE PATIENT (B)(6)DECLARED SHE GOT MUCH ANXIETY AND DID MUCH UNNECESSARY TREATMENT AND TESTING DURING USING OUR PRODUCT- INFRARED THERMOMETER PC828. AS HER DESCRIPTION, WHEN SHE JUST RECOVERED FROM A NON-COVID FLU SYMPTOMS, PC828 STILL CONTINUAL GAVE HER INCONSISTENT AND INCORRECT TEMPERATURE READINGS ABOUT 3 WEEKS, CAUSED HER HAD TO CONSULT PRIMARY CARE MD AND DID MORE TESTS WITH MERCURY THERMOMETER. BASED ON ABOVE PROBLEM, WE HAVE EMAILED AND PHONED (B)(6) AT THE FIRST TIME. IN THE EMAIL, WE TALKED ABOUT RECALL THE UNIT OF HER TO DO FURTHER RESEARCH, INVESTIGATE IF THE PRODUCT FAILURES AND WHAT HAPPENED. MEANWHILE, WE BRIEFLY ILLUSTRATE TO (B)(6) ABOUT HOW TO USE INFRARED THERMOMETER CORRECTLY AND INTRODUCE CHARACTERISTICS OF FEVER ALERT OF OUR PRODUCT PC828, WE SUPPOSE THAT 2 SITUATIONS MAY EXIST: 1. PRODUCT MALFUNCTION; 2. USING METHOD ARE NOT CORRECT. WE ARE EXPECTING THAT (B)(6) CAN COOPERATE US TO DOUBLE CHECK THE PC828 ACCORDING TO CORRECT USING METHOD AND IN A SUITABLE ENVIRONMENT REQUIREMENT, BUT (B)(6) INSIST ON PRODUCT MALFUNCTION. SO WE HAVE INFORMED (B)(6) TO SEND BACK THE PRODUCT FREELY FOR INVESTIGATION AND SHE AGREED, WE WILL SEND HER A NEW ONE. CURRENTLY WE ARE WAITING FOR (B)(6) NEXT ACTION. (B)(6) 03/25/2021

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484118 FLTR INFRARED THERMOMETER FLL SHENZHEN PACOM MEDICAL INSTRUMENTS CO., LTD. PC828

    Patients

    Seq Age Sex Outcome Treatment
    1 Other