inforMED
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AXSYM CMV-G REAGENT KIT

Received Apr 4, 2005 · Event occurred Mar 16, 2005

Report 1415939-2005-00005 · MDR key 588533

Device

Generic name

In Vitro Test Kit For Cmv Antibodies

Model number

NA

Catalog number

4B47-20

Lot number

21188M200

Product problems

  • False Negative Result

Patient

36 YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THE CUSTOMER STATES THAT ONE PATIENT SAMPLE, IN THEIR 14TH WEEK OF PREGNANCY, GENERATED AN INITIAL AXSYM CMV IGG ASSAY RESULT OF 1.5 AU/ML (NEGATIVE). THE SAMPLE REPEATED WITH A RESULT OF GREATER THAN 250 AU/ML. THE PATIENT DILUTED THE SAMPLE AND GENERATED A FINAL RESULT OF 2328.8 AU/ML. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.