MalfunctionJSC
BACT ALERT BLOOD CULTURE BOTTLE
Received Jan 5, 1996 · Event occurred Jan 3, 1996
Report MW1008069 · MDR key 29260
Device
Product problems
- Contamination
- Incorrect, Inadequate or Imprecise Result or Readings
- Microbial Contamination of Device
Patient
*
- Other (for use when an appropriate patient code cannot be identified)
Narrative
Description of Event or Problem
LAB BLOOD CULTURE MEDIUM CONTAINED GRAM-POSITIVE BACTERIA THAT WERE NOT VIABLE, BUT LED RPTR TO CONCLUDE THAT THEY WERE IN THE CULTURE OF THE PT'S SPECIMEN. ONLY ONE LOT OF MEDIA WAS AFFECTED. 10 BOTTLES WHICH WERE KNOWN TO BE NEGATIVE FOR GROWTH OF ORGANISMS WERE GRAM STAINED AND FOUND TO CONTAIN GRAM-POSITIVE COCCI. TEN BOTTLES FROM A DIFFERENT LOT NUMBER WERE FOUND TO BE NEGATIVE BY GRAM STAIN. FOR TWO PTS, POSITIVE REPORTS WERE GIVEN TO THE PHYSICIANS. UNTIL THE PROBLEM WAS RESOLVED THOSE REPORTS REMAINED IN THE PT'S CHART. IN ONE CASE, THE REPORT WAS IN THE COMPUTER FOR 2 WEEKS; IN THE OTHER, FOR 4 DAYS.