ABL800 FLEX Analyzer

Description of Event or Problem

Radiometer complaint reference: CT1-030317According to complaint, the customer reported that during a heart surgery in a baby, one ABL800 analyzer (serial number: (b)(6) measured pH 7,00 (discrepant value). The guys at surgery room complained about this value. laboratory people measured the same sample in another ABL800 analyzer, and they got pH 7,9 (comparison value). They measured in some others ABL800 with a correlated result close to pH 7,9 (comparison value). Another sample came and laboratory people measured again in the ABL800 analyzer (serial number: (b)(6), but at that time all ABL800 measured almost the same value. After that all of them measure the same. With the result of pH 7,00 there were no error messages. It was an aleatory error, but the surgeon is afraid about having another error like that.

Additional Manufacturer Narrative

Date of event is estimated based on the awareness date.