BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIMPROM CONTROL TEST

    MDR report key: 10718530 · Received October 22, 2020

    Report

    Report Number
    1216677-2020-00241
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Date of Event
    October 1, 2020
    Report Date
    November 15, 2022
    Manufacturer
    COOPERSURGICAL INC.
    Product Code
    OAM
    PMA / PMN Number
    K123986
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION. X-NO SAMPLE RETURNED .ANALYSIS AND FINDINGS DISTRIBUTION HISTORY. THE COMPLAINT PRODUCT WAS PURCHASED FROM ACTIM OY. MANUFACTURING RECORD REVIEW: MANUFACTURING RECORD REVIEW NOT APPLICABLE TO THIS PRODUCT. INCOMING INSPECTION REVIEW: A REVIEW OF THE INCOMING INSPECTION RECORD COULD NOT BE PERFORMED AS THE RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. IF THE INCOMING INSPECTION RECORD SHOULD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. SERVICE HISTORY RECORD: SERVICE HISTORY NOT APPLICABLE FOR THIS PRODUCT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT: THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. VISUAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. FUNCTIONAL EVALUATION: EVALUATION OF THE COMPLAINT PRODUCT COULD NOT BE COMPLETED AS THE COMPLAINT PRODUCT HAS NOT BEEN RETURNED TO COOPERSURGICAL. IF THE PRODUCT SHOULD BE RETURNED AT A LATER DATE, IT WILL BE EVALUATED, AND ANY FINDINGS WILL BE APPENDED TO THIS INVESTIGATION. ROOT CAUSE : ROOT CAUSE NOT APPLICABLE AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. CORRECTION AND/OR CORRECTIVE ACTION : COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY, AS THE COMPLAINT CONDITION WAS NOT CONFIRMED. NO FURTHER TRAINING REQUIRED AT THIS TIME PREVENTATIVE ACTION ACTIVITY : COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    (B)(4). REPORT STATED "SEVERAL INSTANCES OF ACTIMPROM SWABS RESULTING NEGATIVE AFTER FOLLOWING APPROPRIATE COLLECTION PROCEDURE. PROVIDER EXAM REVEALED PATIENT TO BE GROSSLY RUPTURED. ". UPDATE-10:13:2020- FOLLOW UP FOR ADDITIONAL INFORMATION STATED- *WAS THERE ANY ADVERSE EFFECT AS A RESULT OF THE REPORTED CONDITION- YOUR REPORT STATED " PROVIDER EXAM REVEALED PATIENT TO BE GROSSLY RUPTURED" ? THIS TEST IS USED TO ASSESS FOR RUPTURE OF AMNIOTIC MEMBRANES IN PREGNANT PATIENTS. THE TESTS IN QUESTION ALL RESULTED NEGATIVE INDICATING THAT RUPTURE OF MEMBRANES HAD NOT OCCURRED. HOWEVER, PROVIDER EXAM REVEALED THE PATIENTS TO BE GROSSLY, OR OBVIOUSLY, RUPTURED WITH APPARENT LEAKING OF AMNIOTIC FLUID. IF THE PROVIDER HAD ONLY USED THE DATA PROVIDED BY THE TEST IN QUESTION, THESE PATIENTS COULD HAVE BEEN DISCHARGED HOME. THIS VASTLY INCREASES THEIR RISK OF INFECTION AND POOR PERINATAL AND NEONATAL OUTCOMES. WAS THERE ANY ADDITIONAL MEDICAL ATTENTION IN THIS REGARDS? NO, BECAUSE THE PROVIDER DID AN ADDITIONAL PHYSICAL EXAM AND DETERMINED THAT THE TEST WAS NOT VALID AND GAVE A FALSE NEGATIVE. DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE? NO. ADDITIONALLY, PROVIDING THE PRODUCT DETAILS - SERIAL OR LOT NUMBER, RELATED INVOICE OR ORDER NUMBER WILL BE VERY HELPFUL. ALL OF THESE INSTANCES HAPPENED HISTORICALLY AND UNFORTUNATELY, I DO NOT HAVE THE LOT NUMBER/ORDER NUMBER AVAILABLE. 1216677-2020-00241 ACTIMPROM CONTROL TEST 30800ETUS (B)(4).

    Additional Manufacturer Narrative · 1

    COOPER SURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    E-COMPLAINT: (B)(4). REPORT STATED, "SEVERAL INSTANCES OF ACTIMPROM SWABS RESULTING NEGATIVE AFTER FOLLOWING APPROPRIATE COLLECTION PROCEDURE. PROVIDER EXAM REVEALED PATIENT TO BE GROSSLY RUPTURED." UPDATE: 10:13:2020: FOLLOW UP FOR ADDITIONAL INFORMATION STATED, "WAS THERE ANY ADVERSE EFFECT AS A RESULT OF THE REPORTED CONDITION." YOUR REPORT STATED, " PROVIDER EXAM REVEALED PATIENT TO BE GROSSLY RUPTURED." THIS TEST IS USED TO ASSESS FOR RUPTURE OF AMNIOTIC MEMBRANES IN PREGNANT PATIENTS. THE TESTS IN QUESTION ALL RESULTED NEGATIVE INDICATING THAT RUPTURE OF MEMBRANES HAD NOT OCCURRED. HOWEVER, PROVIDER EXAM REVEALED THE PATIENTS TO BE GROSSLY, OR OBVIOUSLY, RUPTURED WITH APPARENT LEAKING OF AMNIOTIC FLUID. IF THE PROVIDER HAD ONLY USED THE DATA PROVIDED BY THE TEST IN QUESTION, THESE PATIENTS COULD HAVE BEEN DISCHARGED HOME. THIS VASTLY INCREASES THEIR RISK OF INFECTION, POOR PERINATAL, AND NEONATAL OUTCOMES. WAS THERE ANY ADDITIONAL MEDICAL ATTENTION IN THIS REGARDS? NO, BECAUSE THE PROVIDER DID AN ADDITIONAL PHYSICAL EXAM, AND DETERMINED THAT THE TEST WAS NOT VALID, AND GAVE A FALSE NEGATIVE. DID THE PHYSICIAN PERFORM ANY EXTRA STEP TO COMPLETE THE PROCEDURE? NO. ADDITIONALLY, PROVIDING THE PRODUCT DETAILS, SERIAL OR LOT NUMBER, RELATED INVOICE, OR ORDER NUMBER WILL BE VERY HELPFUL. ALL OF THESE INSTANCES HAPPENED HISTORICALLY AND UNFORTUNATELY, I DO NOT HAVE THE LOT NUMBER/ORDER NUMBER AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188175 ACTIMPROM CONTROL TEST ACTIMPROM CONTROL TEST OAM COOPERSURGICAL INC. 30800ETUS NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other