VACU-TEC TUBES IN THE VES-MATIC ESR TESTING SYSTEM
Received Jun 12, 2001 · Event occurred Jan 16, 2001
Report MW1022192 · MDR key 338408
Device
Generic name
Esr Testing System
Manufacturer
Diesse Diagnostica Senese SriModel number
*Catalog number
*
Lot number
*
Product problems
- Contamination
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IN 1/01, MEDICAL CENTER STARTED UTILIZINGB A NEW PRODUCT, VACU-TEC TUBE IN THE VES-MATIC ESR TESTING SYSTEM FOR DETERMINING THE SEDIMENTATION RATES IN PT POPULATION. A BLOOD CULTURE DRAWN FROM ONE OF PTS YIELDED OCHROBACTRUM ANTHROPI. IT WAS DETERMINED FROM THE PT'S CLINICAL CONDITION AND WORK-UP THAT THIS ORGANISM WAS MOST LIKELY A CONTAMINANT AND THE PT SUBSEQUENTLY WAS NOT TREATED WITH ANTIMICROBIALS. SINCE THIS FIRST CASE AN ADD'L 12 POSITIVES BLOOD CULTURES HAVE GROWN O. ANTHROPI WITH NO CLINICAL DISEASE IN THE 12 PTS. TWO PTS ALSO GREW S. MALTOPHILIA FROM THE SAME BLOOD CULTURE THAT GREW O. ANTHROPI. CLINICAL REVIEW OF PT MEDICAL RECORDS IS ONGOING. FURTHER INFO WILL FOLLOW WHEN COMPLETED.