MalfunctionMXJ
HSV 1&2 TEST
Received Mar 26, 2025 · Event occurred May 18, 2022
Report MW5168292 · MDR key 21701311
Device
Generic name
Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Manufacturer
UnknownPatient
59 YR · Female
- Unspecified Mental, Emotional or Behavioural Problem
- Unspecified Mental, Emotional or Behavioural Problem
Narrative
Description of Event or Problem
RECEIVED FALSE POSITIVE SEROLOGICAL HSV1&2 TEST AS A RESULT OF USING A PANEL TEST. CAUSED MENTAL HARM. WHEN TEST WERE CONDUCTED AT A LATER DATE AND SEPARATELY; THE RESULTS WERE NEGATIVE. NO PHYSICAL SIGNS OR SYMPTOMS PRESENT. LAB STATED HIGHER RISK FOR FALSE POSITIVE RESULTS WHEN TEST ARE CONDUCT USING "PANEL" TEST. ORGANIZATION COLLECTING SEROLOGICAL SPECIMEN STATED THEY REQUEST THE PANEL TEST. DO NOT KNOW THE NAME OF THE PANEL.