Data Innovations

4 recalls Categories: Infusion Pumps, Diagnostic Equipment, Surgical Instruments

Quality control results are not processed for Abbott Diagnostics Alinity ci series (abdicqii) instrument. This has been determined to be a driver malfunction. When an instrument transmits results from a quality control (QC) sample ID ("Q^Control" in SPM segment), and the option Hold Results Until Complete is enabled, the results do not parse into IM. The communication Trace shows the sample being transmitted, but no information is logged in the Specimen Event Log (SEL). There is a potential for harm if QC results are not processed, downstream auto verification rules may misfire based on missing QC results leading to a delay in, or incorrect treatment. QC results will not be available for evaluation by the lab. There have been no reported instances of patient harm from this malfunction.

Aug 29, 2018 Infusion Pumps View Details →

Software issue resulting in the results of one patient potentially being associated with another.

Oct 23, 2014 Diagnostic Equipment Nationwide View Details →

Potential issues with the ProVue driver have been identified which may cause data to be misassociated with patient results under a given set of circumstances.

Aug 15, 2014 Diagnostic Equipment Nationwide View Details →

When connected to the Sysmex UF-100, the Instrument Manager driver sysu100i driver software versions 7.00.0001, 7.00.0002, 7.00.0003, 7.00.0004, 7.00.0005, 8.00.0001, 8.00.0002, 8.00.0003, and 8.00.0004, and is configured with option "Strip Zeros from Result" set to "Yes" may result in sample error

Nov 6, 2013 Surgical Instruments Nationwide View Details →