CULTURETTE TOXIN CD
Received Apr 23, 1999 · Event occurred Mar 24, 1999
Report 1119779-1999-00002 · MDR key 220327
Device
Generic name
Rapid Immunoassay Test
Manufacturer
Becton DickinsonModel number
NACatalog number
4954004
Lot number
1000C9FGIF
Product problems
- False Negative Result
Patient
79 YR
- Death
- Other (for use when an appropriate patient code cannot be identified)
- Surgical procedure
- Treatment with medication(s)
Narrative
Description of Event or Problem
A 79 YEAR OLD FEMALE WAS ADMITTED TO THE HOSPITAL FOR UNKNOWN REASONS. DURING THE COURSE OF HOSPITALIZATION SHE WAS PLACED ON MULTIPLE, BROAD-SPECTRUM ANTIBIOTICS FOR SUSPECTED SEPSIS. AT SOME POINT SHE DEVELOPED DIARRHEA, THAT WAS VISUALLY BLOODY AT TIMES. THE SOURCE OF THE BLOOD IN HER STOOLS WAS NEVER DETERMINED AND THE PT SUBSEQUENTLY HAD A NEAR-TOTAL COLECTOMY AND EXPIRED THEREAFTER. SHE HAD FIVE STOOL SPECIMENS TAKEN OVER A PERIOD OF FOUR DAYS WHICH WERE TESTED WITH THE DEVICE. ALL RESULTS WERE REPORTED AS NEGATIVE. THE PATHOLOGY OF THE EXCISED COLON SHOWED "MASSIVE PSEUDOMEMBRANOUS COLITIS," WITHOUT COLONIC PERFORATIONS OR EVIDENCE OF TOXIC MEGACOLON. THERE WAS NEVER ANY CONFIRMATION BY ANY OTHER METHOD THAT CLOSTRIDIUM DIFFICILE WAS THE ETIOLOGIC AGENT FOR THE PSEUDOMEMBRANOUS COLITIS.