Maryland General Hospital officials said they expect to file a report with the Food and Drug Administration this week charging that an automated blood analyzer it purchased was defective and should be investigated for its reliability.
The laboratory equipment in question tested thousands of patients for HIV and hepatitis C from June 2002 to August 2003, but lab workers manipulated the quality-control readings on 10% to 15% of the tests and sent them out instead of following procedures to have those tests redone, according to a report from state inspectors made public earlier this month.
Meanwhile, the hospital and the equipment's manufacturer, Adaltis U.S., were named in a multimillion-dollar lawsuit by a former lab technician at Maryland General who contends she contracted HIV and hepatitis C as a result of a malfunction involving the Labotech blood analyzer.
The 32-year-old technician told her story last week to the Baltimore Sun.
In a statement, the hospital said the analyzer has not been used since August 2003 when "technical limitations . . . in handling a growing volume of tests" prompted the facility to send test specimens to a private lab. Letters were sent March 11 to about 400 people whose test results were manipulated, asking them to come in for retesting at no charge.