BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ID NOW COVID-19

    MDR report key: 10681287 · Received October 14, 2020

    Report

    Report Number
    1221359-2020-00311
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 15, 2020
    Report Date
    March 24, 2021
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA2000074
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PURPOSE OF THIS SUPPLEMENTAL REPORT IS TO CORRECT INFORMATION THAT WAS PROVIDED IN SUPPLEMENT 1, DATED 22-JAN-2021. THE ROOT CAUSE OF THE COMPLAINT WAS INCORRECTLY ATTRIBUTED TO IMPROPER LINE CLEARANCE. WHEN USING THE STICK FEEDER SWITCH ON THE FOAM TIPPING EQUIPMENT. THE ROOT CAUSE PROVIDED BY PURITAN MEDICAL PRODUCTS, LLC WAS SPECIFIC TO PART NUMBER: (B)(4), LOT NUMBER: (B)(4). THIS LOT WAS REJECTED AT INCOMING INSPECTION AND WAS NOT DISTRIBUTED. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, THE ROOT CAUSE, INDICATED IN SUPPLEMENT 1, CANNOT BE SPECIFICALLY LINKED TO THE ROOT CAUSE OF THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER, PURITAN MEDICAL PRODUCTS COMPANY, LLC, REPORTED THAT THE ROOT CAUSE OF THE FOAM TIP FALLING OFF THE SHAFT WAS ATTRIBUTED TO IMPROPER LINE CLEARANCE WHEN USING THE STICK FEEDER SWITCH ON THE FOAM TIPPING EQUIPMENT. IT WAS DISCOVERED THAT THE FOAM OPERATORS INADVERTENTLY USED THE STICK FEEDER SWITCH INSTEAD OF THE CYCLE SWITCH AT START UP AND DID NOT DISCARD THE START-UP SWABS. THE FEEDER SWITCH ADVANCES THE SWAB STICKS, BUT ADHESIVE WILL NOT BE APPLIED CAUSING SWABS TO BE PRODUCED WITH NO ADHESIVE. THE NUMBER OF SWABS IMPACTED IS EXPECTED TO BE LOW BASED ON THE ROOT CAUSE ANALYSIS. THEREFORE NO FURTHER ACTION IS NEEDED.

    Additional Manufacturer Narrative · 1

    INCOMING INSPECTION RECORDS WERE REVIEWED FOR THE SWAB PROVIDED IN THE ID NOW COVID-19 KIT, WHICH IS MANUFACTURED BY PURITAN MEDICAL PRODUCTS COMPANY, LLC, PN: 25-1506 1PFB AND PN: 25-1506 100. INSPECTION IS DESIGNED TO TEST THE DURABILITY OF THE SWAB UNDER NORMAL USE CONDITIONS IN A HEALTH CARE FACILITY. PURITAN MEDICAL PRODUCTS COMPANY, LLC (SWAB MANUFACTURER) WAS NOTIFIED OF THE COMPLAINT. AN INVESTIGATION WAS UNABLE TO BE PERFORMED PRIOR TO THE INITIAL MDR SUBMISSION TIMELINE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA IF THE SWAB MANUFACTURER PROVIDES INTERNAL INVESTIGATION INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TWO (2) INSTANCES THE FOAM-TIP COMING OFF OF THE KITTED NASAL SWABS PROVIDED WITH ID NOW COVID-19 ASSAY. ONE OCCURRED AT THE TIME OF COLLECTION (NOT FURTHER SPECIFIED BY REPORTER) AND ONE AT TIME OF TESTING (ALSO NOT FURTHER SPECIFIED). NO FURTHER INFORMATION WAS PROVIDED. ATTEMPTS TO GAIN FURTHER INFORMATION WERE UNSUCCESSFUL. THE COLLECTION SWABS PROVIDED IN THE ID NOW COVID-19 KIT ARE MANUFACTURED BY PURITAN MEDICAL PRODUCTS COMPANY, LLC. (PN: 25-1506 1PFB OR 25-1506 1PF 100), AND RECEIVED AT ABBOTT DIAGNOSTICS (B)(4). WHERE THEY ARE INSPECTED AND THEN ADDED TO THE ASSAY KITS. THE CUSTOMER DID NOT REPORT ANY PROBLEMS WITH THE ID NOW COVID-19 ASSAY. THE COMPLAINT IS EXCLUSIVELY CONCERNING THE PURITAN STERILE COLLECTION SWAB PROVIDED IN THE ASSAY KIT. ALTHOUGH THERE WAS NO INJURY/AE RELATED TO THIS CASE, THIS CASE SHALL BE CONSIDERED REPORTABLE BECAUSE IT WAS UNKNOWN AT WHICH PHASE OF COLLECTION THE SWAB TIP FELL-OFF, AND SWABS BREAKING/SWAB TIPS FALLING OFF IN PATIENTS' NOSE MIGHT LEAD TO AN ADVERSE OUTCOME IN A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1143388 ID NOW COVID-19 MOLECULAR IVD FOR ID NOW COVID-19 QJR ABBOTT DIAGNOSTICS SCARBOROUGH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1