FDA Adverse Event Malfunction Summary report: N

OXYRASE

MDR report key: 402329 · Received June 26, 2002

Report

Report Number
MW1025434
Event Type
Malfunction
Date Received
June 26, 2002
Date of Event
May 12, 2002
Report Date
June 20, 2002
Manufacturer
OXYRASE, INC.
Product Code
JSM
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

BACKGROUND: YERSINIOSIS IS A REPORTABLE DISEASE IN RPTR'S STATE. FROM 1997 TO 2001, 48-69 CASES WERE REPORTED ANNUALLY (MEDIAL OF 53 CASES PER YEAR). MOST OF THESE CASES ARE DUE TO INFECTION WITH YERSINIA ENTEROCOLITICA, BUT OCCASIONALLY OTHER SPECIES ARE REPORTED. SOURCE OF THE ISOLATE IS NOT ALWAYS REPORTED. MOST ISOLATES COME FROM STOOL (14-26 PER YEAR), WITH A FEW FROM URINE (1-4 PER YEAR) OR BLOOD (1-5 PER YEAR). DURING THE YEARS 1997 TO 2001, ONLY ONE ISOLATE FROM A WOUND WAS REPORTED (2001). IN ADDITION TO CASES BEING REPORTED THROUGH THE USUAL DISEASE REPORTING CHANNELS, ISOLATES ARE SOMETIMES RECEIVED AT DEPT OF HEALTH LAB FOR IDENTIFICATION. THESE REPORTS WOULD ALSO BE INCLUDED IN THE DISEASE STATISTICS. THIS IS THE CONTEXT IN WHICH THE CURRENT REPORTS OCCURRED. SUMMARY: EIGHT ISOLATES OF YERSINIA SPP FROM SOURCES OTHER THAN STOOL OR URINE WERE REPORTED TO THE DEPT OF HEALTH IN APRIL AND MAY, 2002; AN ADD'L ONE IS PENDING. THEY WERE ALL OBTAINED POST-SURGERY. INITIALLY, THE LAB FOR FACILITIES A AND B (ACTUALLY LOCATED AT FACILITY A) REPORTED 5 ISOLATIONS FROM POST-SURGICAL SPECIMENS. LAB VERIFIED THE IDENTIFICATION OF THESE ISOLATES AS YERSINIA ENTEROCOLITICA. BY PULSED-FIELD GEL ELECTROPHORESIS (PFGE) 4 WERE IDENTICAL; REFERRED TO BY LAB AS PATTERN 1. PFGE ON THE FIFTH ISOLATE IS UNDERWAY. THE LAB FOR FACILITIES A AND B RECOVERED THE YERSINIA ENTEROCOLITICA ON "CDC BLOOD AGAR OXYPLATE" MFG BY OXYRASE (SEE WWW.OXYRASE.COM. OXYRASE, INC; P.O. BOX 1345, MANSFIELD, OH 44901; TEL 419/589-8800). THIS IS AN ANAEROBIC BLOOD AGAR PLATE. FACILITY A DETERMINED THAT THE OXYPLATE WAS THE SOURCE OF THE YERSINIA, AND CONTACTED THE CO TO REPORT THEIR FINDINGS THAT THE PLATES WERE CONTAMINATED. FACILITY C REPORTED A POST-SURGERY FINDING OF YERSINIA ENTEROCOLITICA. LAB VERIFIED THE IDENTIFICATION AND PFGE ANALYSIS IDENTIFIED IT AS DISTINCT FROM PATTERN 1; IT IS CALLED PATTERN 2. THIS LAB WAS USING PLATES FROM BECTON DICKINSON (INITIALLY THEY REPORTED USING PLATES FROM BBL). FACILITY D GREW YERSINIA SPP FROM A POST-SURGICAL SWAB RECEIVED FROM A DR'S OFFICE. THEY FORWARDED THE ISOLATE TO HEALTH DEPT LAB FOR FURTHER IDENTIFICATION, WHERE IT WAS IDENTIFIED AS YERSINIA KRISTENSENII. THIS LAB WAS USING PLATES FROM BBL. FACILITY E GREW YERSINIA FROM A POST-SURGICAL SWAB FROM A DR'S OFFICE. THEY FORWARDED IT TO FACILITY D, WHO SENT IT ON TO LAB WITHOUT DOING ANYTHING TO IT. LAB IDENTIFIED IT AS YERSINIA ENTEROCOLITICA, PFGE PATTERN 3, DISTINCT FROM PATTERNS 1 AND 2. FACILITY E LAB WAS USING PLATES FROM BECTON DICKINSON. LASTLY, THERE IS AN ISOLATE PENDING FROM FACILITY F, WHICH REPORTED FINDING YERSINIA ENTEROCOLITICA IN A GALLBLADDER. THIS ISOLATE WAS SUBMITTED TO LAB IN RESPONSE TO A MEMO SENT TO ALL MICROBIOLOGY LABS IN STATE BY HEALTH DEPT ON 5/2002, SOLICITING ALL NON-STOOL ISOLATES OF Y. ENTEROCOLITICA. FACILITY F LAB WAS USING MEDIA FROM BBL. LAB IS IN THE PROCESS OF IDENTIFYING THIS ISOLATE (6/2002). (NOTE: IT APPEARS THAT BECTON DICKINSON SELLS BBL MEDIA). IN SUMMARY, THIS CLUSTER OF POST-SURGICAL SPECIMENS YIELDING YERSINIA SPP IS VERY UNUSUAL IN THE STATE, WHERE MOST YERSINIOSIS IS REPORTED FROM STOOL CULTURES, FROM PTS HAVING DIARRHEA. THE PRESENCE OF TWO SPECIES OF YERSINIA, AND 3 STRAINS OF Y. ENTEROCOLITICA SUGGESTS A MIXED YERSINIA FLORA IS INVOLVED. DETAILED CASE REPORTS: CASES 1,2,3,4 AND 10 ARE ASSOCIATED WITH FACILITIES A AND B. THESE ARE TWO SEPARATE HOSPS THAT ARE AFFILIATED. THEY SHARE ONE LAB (LOCATED AT FACILITY A). THEY ORDER SUPPLIES TOGETHER. THEY ARE NOT AFFILIATED WITH ANY OTHER FACILITY. THE INITIAL REPORT CAME FROM A COUNTY HEALTH DEPT THAT FACILITIES A AND B WERE REPORTING TWO POSITIVE YERSINIA CULTURES OCCURRING WITHIN 2 DAYS FROM POST-SURGICAL PTS. THIS PT CAME TO FACILITY B AS A DIABETIC PT FOR TOE SURGERY. A CULTURE TAKEN BEFORE THE SALINE IRRIGATION WAS POSITIVE FOR YERSINIA ENTEROCOLITICA. PT HAD NOT RECEIVED ANY BLOOD TRANSFUSION, NOR DID THEY HAVE ANY HISTORY OF DIARRHEA. LAB LATER VERIFIED THIS WAS Y. ENTEROCOLITICA, AND PFGE PATTERN WAS PATTERN 1. AFTER FINDING FOUR POSITIVES IT WAS THE CONCLUSION AT FACILITY A THAT THE YERSINIA WAS ORIGINATING FROM THE "CDC BLOOD AGAR OXYPLATE. WITH THEIR FIFTH ISOLATE THEY CONFIRMED THEIR SUSPICION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 OXYRASE BLOOD AGAR JSM OXYRASE, INC. * *

Patients

Seq Age Sex Outcome Treatment
1 NO INFO Other