MAUDE Adverse Event Report: BIO-RAD LABORATORIES, INC. BIOPLEX 2200; ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  malfunction  

Event Description

Covid vaccine possibly caused false positive result with syphilis lab test.Original lab test that was conducted on (b)(6) was reactive minimal.I had another lab rpr, rfx qn rpr/confirm tp-012005 and the result was negative.I received moderna covid vaccine on (b)(6).Fda safety report id# (b)(4).

• Brand Name: BIOPLEX 2200
• Type of Device: ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM
• Manufacturer (Section D): BIO-RAD LABORATORIES, INC.
• MDR Report Key: 13093186
• MDR Text Key: 282898791
• Report Number: MW5106283
• Device Sequence Number: 1
• Product Code: LIP
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian