Description of Event or Problem · 0
THE (B)(6 DEPARTMENT OF HEALTH PUBLIC HEALTH LABORATORY (MDH-PHL) OPENED AN INVESTIGATION IN AUGUST 2024 AFTER AN INCREASE IN SUBMITTED PARABURKHOLDERIA FUNGORUM ISOLATES FROM BLOOD CULTURES. THESE ISOLATES WERE SUBMITTED FROM 3 (B)(6) CLINICAL LABORATORIES FOR ASSISTANCE WITH IDENTIFICATION. THE INCREASE IN SUBMITTED ISOLATES WAS NOTABLE SINCE (B)(6) HAD NOT BEEN IDENTIFIED BY MDH-PHL SINCE 2011. TO DATE, THIS INVESTIGATION HAS RESULTED IN THE IDENTIFICATION OF 23 PATIENTS WITH POSITIVE BLOOD CULTURES FOR PARABURKHOLDERIA FUNGORUM OR PARABURKHOLDERIA SPECIES ACROSS (B)(6). MDH-PHL NOTIFIED OTHER LABS IN (B)(6) IN OCTOBER 2024 AND AN ADDITIONAL 30 ISOLATES FROM PATIENTS HOSPITALIZED IN OTHER STATES WERE SUBSEQUENTLY IDENTIFIED ((B)(6)). (B)(6) CASE RECORDS WERE REVIEWED BY A MEDICAL EPIDEMIOLOGIST AT (B)(6) AND IN ALL CASES THE POSITIVE BLOOD CULTURES WERE DEEMED POTENTIAL CONTAMINANTS RATHER THAN TRUE INFECTIONS. (B)(6) INITIALLY COMPLETED WHOLE GENOME SEQUENCING (WGS) OF 7 (B)(6) CLINICAL ISOLATES, INCLUDING RELATEDNESS ASSESSMENT, WHICH SUGGESTED ALL ISOLATES WERE RELATED. (B)(6) SUBMITTED AN INITIAL FDA MEDWATCH REPORT IN 2024 DETAILING THESE FINDINGS (CASE NUMBER (B)(4)), WITH INITIAL CONCERN FOCUSING ON POTENTIAL CONTAMINATION OF BLOOD CULTURE BOTTLES MANUFACTURED BY BD BACTEC. SUBSEQUENT TO THAT INITIAL MEDWATCH REPORT, (B)(6) HAS BEEN IN CONTACT WITH CLINICIANS AND CLINICAL MICROBIOLOGISTS FROM OTHER JURISDICTIONS WHO IDENTIFIED SIMILAR CASES OF PARABURKHOLDERIA FUNGORUM OR PARABURKHOLDERIA SPECIES IN BLOOD CULTURES; (B)(6) HOSPITAL IN (B)(6), THE PUBLIC HEALTH LABORATORY IN (B)(6). NOTABLY, HMO HAD IDENTIFIED 2 CASES WHERE ISOLATES FROM PERITONEAL FLUID INJECTED INTO BLOOD CULTURE BOTTLES WERE POSITIVE FOR P. FUNGORUM. HMO IDENTIFIED A U.S. MANUFACTURED NON-STERILE ULTRASOUND GEL USED AT POINT OF- CARE FOR GUIDING BLOOD DRAWS AND PARACENTESIS AS A POSSIBLE RISK FACTOR. CULTURES OF MULTIPLE GEL BOTTLES FROM HMO, (B)(6) ARE POSITIVE FOR P. FUNGORUM. MDH-PHL HAS NOW COMPLETED WHOLE GENOME SEQUENCING ANALYSIS OF 45 P. FUNGORUM ISOLATES (39 CLINICAL ISOLATES FROM PATIENTS, 6 ISOLATES FROM ULTRASOUND GEL) FROM (B)(6), SHOWING THAT ALL ISOLATES ARE 0-23 SINGLE NUCLEOTIDE POLYMORPHISMS (SNPS) APART, WITH MULTIPLE SUBCLUSTERS OF AS LITTLE AS 0-8 SNPS APART. THIS STRONGLY SUGGESTS GENETIC RELATEDNESS AMONG ISOLATES AND IMPLICATES NON-STERILE ULTRASOUND GEL AS THE COMMON SOURCE FOR THIS PSEUDO-OUTBREAK. THE BRANDS OF ULTRASOUND GEL THAT HAVE BEEN CONNECTED TO CASES SO FAR INCLUDE: CLEAR IMAGE, NEXT MEDICAL, MEDICHOICE, ECO-MED PHARMACEUTICAL CLINICAL MICROBIOLOGISTS AT HMO AND IN CANADA HAVE NOTIFIED THE MANUFACTURER OF CLEAR IMAGE GEL (NEXT MEDICAL) WHO HAVE REPORTED THAT THEY WERE AWARE OF THE ISSUE OF P. FUNGORUM CONTAMINATION AND HAVE NOTIFIED THE U.S. FOOD AND DRUG ADMINISTRATION (FDA). IT WAS NOT POSSIBLE TO DETERMINE WITH ABSOLUTE CERTAINTY WHETHER ANY CASES REPRESENTED INVASIVE INFECTION WITH P. FUNGORUM, HENCE THIS DESIGNATION AS A PSEUDO-OUTBREAK. HOWEVER, THE ACTUAL AND POTENTIAL HARMS TO PATIENTS DUE TO LIKELY FALSE-POSITIVE CULTURES FOR P. FUNGORUM SEEN IN THIS INVESTIGATION INCLUDE UNNECESSARY OR PROLONGED COURSES OF ANTIBIOTICS, CLINICAL UNCERTAINTY INCLUDING MISDIAGNOSIS OF SEPSIS, AND EXCESSIVE COSTS ASSOCIATED WITH LABORATORY PROCESSING AND ANTIBIOTIC USE. REF REPORTS: MW5167987 AND MW5167988.