WELLCOGEN BACTERIAL ANTIGEN KIT ZL26

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-02-03 for WELLCOGEN BACTERIAL ANTIGEN KIT ZL26 manufactured by Murex Diagnostics, Inc..

Event Text Entries

[8086] A 3-yr-old child was admitted to the er on 1/10/94 with nausea, vomiting and complaint of a headache. The child also had blue splotches over her entire body. A spinal tap was performed along with other lab work. The lab performed a culture, gram stain, latex meningitis panel, glucose, protein and cell count on the csf. 1) the glucose and protein were normal. 2) on the cell count the appearance was clear and colorless, 5 wbc and 6 rbc. 3) the gram stain showed no pmns and no bacteria seen. 4) this latex meningitis panel showed all 5 antigens were negative. They include streptococcus group b, h. Influenzae type b, s. Pneumoniae, n. Meningitidis a, b, c, y, w135 and e. Coli k1. 5) coagulation studies were also performed with elevated pt, ptt and fdp. 6) a liver profile was done with elevated alk, phos, ld and sgot. 7) the cbc had a wbc of 2. 8, a plt count of 26 and a reversed diff. The pt was then transfered to a picu unit at another hosp where she died. They preformed a latex meningitis panel on serum at the other hosp where they got a positive n. Meningitidis a, c, y, w135. It must be noted that the kit used was also this co's bacterial antigen kit. The following day rptr was told that the child had died of neisseria meningitidis. Rptr was concerned because the gram stain showed no wbcs and no bacteria, also the cultures were no growth at 14 hrs (both blood and csf cultures). On investigation rptr discovered that the hosp in which the child was transfered preformed a meningitis antigen panel and got a positive agglutination to the n. Meningiditis a, c, y, w135. With this knowledge, rptr pulled the spinal fluid reruning the tech's sample, reprocessing a new sample, and because rptr was in a hurry, rptr ran the csf straight. The results of rptr's study were: 1) the sample performedby the night tech was as she reported: all negative. 2) the sample rptr reprocessed was also all negative. 3) but the sample that was not processed and run straight was positive for neisseria meningitidis a, c, y, w135. (the control was negative). 4) the csf culture at 22 hrs showed growth of 3 colonies of gram negative diplococcus that was oxidase positive. 5) the next day sugars, were run with an id of neisseria meningitidis. 6) the speciman was sent to the state lab for typing with a finding of type c. The mfr was phoned as soon as rptr noted the problem.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1000631
MDR Report Key11260
Date Received1994-02-03
Date of Report1994-01-13
Date of Event1994-01-10
Date Added to Maude1994-02-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameWELLCOGEN BACTERIAL ANTIGEN KIT
Product CodeGTI
Date Received1994-02-03
Catalog NumberZL26
Lot Number3312J
Device Expiration Date1994-04-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key11260
ManufacturerMUREX DIAGNOSTICS, INC.
Manufacturer AddressNORCROSS GA 30071 US


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1994-02-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.