Udi: (b)(4) the customer reported patient results for na and k with a significant difference to laboratory values from same sampling time.The samples were run on prime plus analyzer with blood gas sensor card lot 21281009, calibrator pack lot 21252047 and qc pack lot 21047090.The event was first observed on (b)(6), 2021.As per customer, there was no patient harm or medical intervention.Device history record (dhr) reviews for the prime plus sensor card lot 21281009, prime plus aqc lot 21047090, prime plus calibrator lot 21252047, prime plus analyzer sn (b)(6) and prime plus reference cartridge lot 21203017 were performed by the quality control manager.The review included an assessment of the production, testing, and release of the analyzer and consumables.No abnormalities or concerns were observed; the dhr indicated that the released product met all specifications.The customer database was reviewed.It was determined that the reference sensor had been installed on the analyzer almost 2 months.During that time the slopes for na and k were drifty but not out of range.As soon as the reference was replaced slope values became more stable.Testing of retained reference cartridge was not possible as it was not returned from the field and retain is not available.As part of initial troubleshooting, new reference sensor was installed and results returned to expected ranges.No other actions were identified.
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