MAUDE Adverse Event Report: QIAGEN AMNISURE; IMMUNOASSAY FOR DETECTION OF AMNIOTIC FLUID PROTEIN(S).

Lot Number 57203698

Device Problem False Negative Result (1225)

Patient Problem Fluid Discharge (2686)

Event Date 11/15/2022

Event Type  malfunction  

Event Description

Pt came into triage reporting questionable rupture of membranes.Pt denied having leaking on chux on admission.Dr (b)(6) called for amnisure.Amnisure performed, noted to have fluid coming out of hollow end of q-tip during procedure.This rn nitrazined fluid leaking from amisure q-tip and immediately positive.While awaiting 10 min for amnisure pt report large amount of leaking on chux, chux changed per rn and were saturated with fluid, nitrazine positive of fluid on chux.After 10 min noted amnisure to be negative.Dr (b)(6) decided then to perform ferning.Md performed fern test and reported back pt was positive for ferning and thus rupture of membranes.Fda safety report id # (b)(4).

• Brand Name: AMNISURE
• Type of Device: IMMUNOASSAY FOR DETECTION OF AMNIOTIC FLUID PROTEIN(S).
• Manufacturer (Section D): QIAGEN
• MDR Report Key: 15834368
• MDR Text Key: 304115609
• Report Number: MW5113380
• Device Sequence Number: 1
• Product Code: NQM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/25/2024
• Device Lot Number: 57203698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1