THIOGLYCOLLATE VITAMIN K AND HEMIN
Received Dec 3, 2008 · Event occurred Nov 3, 2008
Report 1280623 · MDR key 1280623
Device
Generic name
Microbiology Culture Media
Manufacturer
Becton DickinsonModel number
*Catalog number
*
Lot number
8164953
Product problems
- False Negative Result
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
GRAM STAIN RESULTS YIELDED GRAM POSITIVE BEADED ORGANISMS ON MULTIPLE SPECIMENS WHICH WERE GROUNDED USING THIOGLYCOLLATE. NO ORGANISMS WERE SEEN WHEN THE SAME SPECIMENS WERE TESTED AGAIN WITHOUT USING THIOGLYCOLLATE. THE MEDIA WAS FOUND TO HAVE HIGH COUNTS OF NONVIABLE ORGANISMS.====================== MANUFACTURER RESPONSE FOR MICROBIOLOGY CULTURE MEDIA, THIOGLYCOLLATE VITAMIN K AND HEMIN======================THE RESPONSE WAS THAT A GRAM STAIN BY ITSELF CAN NEITHER RULE IN OR OUT INFECTION SINCE ARTIFACTS AND NON-VIABLES MAY BE PRESENT IN THE TRANSPORT MEDIA. MOST LIQUID MEDIA WILL HAVE SOME LEVEL OF MICROORGANISMS PRESENT IN THE PRODUCT.THE BATCH HISTORY RECORD WAS REVIEWED AND WAS FOUND TO BE SATISFACTORY. THERE WAS NO EVIDENCE OF CONTAMINATION IN THE RETENTION SAMPLE. THERE WAS NO EVIDENCE OF CONTAMINATION IN THE RETURN SAMPLE.