LACT GEN.2 03183700190

[114822894] This event occurred in (b)(6). Medwatch field facility name - the full facility name was provided as (b)(4).
Patient Sequence No: 1, Text Type: N, H10

[114822895] The customer stated that they received an erroneous result for one patient sample tested for lact2 lactate gen. 2 (lact) on a cobas integra 400 plus (i400+). The sample initially resulted as 0. 11 mmol/l and this value was reported outside of the laboratory to the ward. The result did not match previous results of the patient, so the ward complained about the result. Controls were measured on the lact assay and they were found to be too low. The customer changed the reagent cassette and repeated the sample. The repeat result of the sample was 1. 78 mmol/l. Controls were repeated on the new cassette and the values were within range, matching previous values. No adverse events were alleged to have occurred with the patient. The i400+ analyzer serial number was (b)(4). The investigation was unable to find a definitive root cause.
Patient Sequence No: 1, Text Type: D, B5