Maryland Hospital Asks FDA to Examine Testing Equipment After Possible Incorrect HIV, Hepatitis Test Results

officials have said that they will ask FDA to investigate the reliability of the hospital's blood testing equipment after reports that the hospital may have released hundreds of incorrect HIV and hepatitis test results, the Baltimore Sun reports (Roche, Baltimore Sun, 3/20). Maryland officials earlier this month said that approximately 460 patients may have received incorrect test results after hospital laboratory personnel overrode controls in the testing equipment that indicated the results might be in error. State officials discovered the problem in January after a former hospital employee filed a complaint. State inspectors -- who conducted interviews with hospital personnel and reviewed medical records -- discovered that as a result of the laboratory staff's failure to follow standards set by the manufacturers of the tests, 10% to 15% of the HIV tests performed during the 14-month period ending in August 2003 may have produced inaccurate results (Kaiser Daily HIV/AIDS Report, 3/18). However, hospital officials reported in an official statement that they believe the analyzer itself -- not improper employee methodology -- may have caused inaccurate test results(Baltimore Sun, 3/20). Five years ago, Britain's National Health Service issued a warning that the Adaltis US-manufactured Labotech analyzers have intermittent failures "possibly resulting in false negative test results." MedWatch, an FDA database of reported problems with medical devices, contains no references to the analyzers, according to the Sun (Baltimore Sun, 3/20).

Thousands at Risk?
Former lab worker Kristin Turner, who is suing the hospital and Adaltis US for a machine malfunction she says infected her with HIV and hepatitis C, said on Friday that the actual number of patients who received false HIV test results could be in the thousands. She said, "Every single test that came off that machine should be in question from its first day in use." Turner said the machine had been unreliable since she was first trained to use it in October 2002, and technicians from Adaltis were either contacted by lab workers or sent to the hospital "several times a week" because of machine malfunctions, the Associated Press reports. Turner added that she complained about the analyzer shortly after she was trained on it, but her warnings were ignored, the Associated Press reports (Klug, Associated Press, 3/20).

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