Instrumentation laboratory conducted an investigation that included a review of data files from the customer's gem premier 4000 blood gas analyzer.Investigation of sample data did not identify any failures with the ph sensor; however, the sensor file showed a ph recovery of 7.17, not 7.11 as indicated by the customer.Per the clinical assessment done by instrumentation laboratory for a ph < 7.2, the physician's decision to proceed with an urgent caesarian section is consistent with current recommendations.The investigation confirmed that there was no product malfunction and therefore no remedial action is indicated.
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The manufacturer received a complaint indicating questionable fetal scalp ph results after a ph result of 7.11 was displayed on a gem premier 4000 system.However, the result could not be retrieved in the instrument after an error message was displayed ("air detected within sample.Displayed results questionable").Based upon the displayed result, the physician was notified, and the decision was made to proceed with an urgent caesarian section.
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