inforMED
MalfunctionJSC

VERSATREK REDOX EZ DRAW PURPLE AEROBIC

Received Feb 22, 2012 · Event occurred Feb 13, 2012

Report 2467633 · MDR key 2467633

Device

Generic name

Aerobic Blood Culture Bottle

Model number

7106-44

Catalog number

*

Lot number

154777SA

Product problems

  • False Positive Result

Patient

*

  • No Code Available

Narrative

Description of Event or Problem

A BLOOD CULTURE COLLECTED WENT POSITIVE AND THE GRAM STAIN SHOWED GRAM POSITIVE COCCI IN CHAINS. THE SPECIMEN WAS PLATED TO AGAR PLATES PER PROTOCOL. AFTER 24 HOURS, NO ORGANISM GREW. SELECTIVE MEDIA WAS THEN INOCULATED AND INCUBATED 24 HOURS IN ORDER TO GET THE ORGANISM TO GROW. TWO DAYS AFTER THE INITIAL POSITIVE REPORT MICROBIOLOGY DETERMINED THE ORGANISM WAS NOT VIABLE, AMENDED REPORT AND REPORTED AS NO GROWTH. SINCE THAT TIME, MICROBIOLOGY HAS RECORDED THAT THIS REPORT WAS A FALSE POSITIVE. WE HAVE HAD A TOTAL OF SIX FALSE POSITIVES BLOOD CULTURES, FIVE OF WHICH WERE FROM THE SAME LOT NUMBER OF REDOX EZDRAW AEROBIC BOTTLES LOT 154777SA. NONE OF THESE FALSE POSITIVES WERE REPORTED ON PATIENTS. MICROBIOLOGY GRAM STAINED SOME OF THE UN-INOCULATED BLOOD CULTURE BROTHS FROM THE LOT NUMBER IN QUESTION AND VERIFIED THAT THE "ORGANISM" IS PRESENT IN THE BOTTLE BEFORE PATIENT SAMPLE IS ADDED. THIS FALSE POSITIVE MAY HAVE CAUSED THE PATIENT TO BE HOSPITALIZED AND TREATED WITH ANTIBIOTICS NEEDLESSLY.