inforMED
MalfunctionPMN

ASSAYED EXTERNAL CONTROL MATERIAL FOR MICROBIOLOGY NUCLEIC ACID AMPLIFICATION

Received Mar 9, 2023 · Event occurred Dec 8, 2022

Report 16512079 · MDR key 16512079

Device

Generic name

Assayed External Control Material For Microbiology Nucleic Acid Amplification

Product problems

  • Human-Device Interface Problem
  • Fail-Safe Did Not Operate

Patient

10585 DA · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DURING TEST PREPARATION, REAGENT COMPONENT WAS OMITTED. TEST PROCESSED AS NORMAL, AND INSTRUMENT DID NOT FLAG UNACCEPTABLE TEST PREPARATION. A NEGATIVE RESULT WAS REPORTED SINCE ALL QUALITY METRICS WERE MET. BY CHANCE, THIS SAMPLE WAS REPEATED FOR BIANNUAL INSTRUMENT COMPARISON AND A POSITIVE RESULT WAS OBTAINED. A SECOND TECH REPEATED THE TEST ON A FRESH SAMPLE AND VERIFIED THE POSITIVE RESULT. VENDOR NOTIFIED OF FAILURE OF TEST SYSTEM TO NOTIFY OF IMPROPER SAMPLE PREPARATION. PROVIDER NOTIFIED OF ERROR WITHIN 24 HOURS AND THE ERROR DID NOT ALTER THE PATIENT'S TREATMENT COURSE.