Evaluation summary: this report is based on information provided by the global complaint handling system.The product sample was not returned to the medtronic laboratory; however, a accuview graph was provided by the customer for analysis.The customer reported, they had a study with blue lines.The reported condition was confirmed.The investigation found that: a.The total study duration is 48 hours which indicates a performance of full study and proper function of bravo ph recorder, b.The ph capsule transmitted values at the first 11 hours of the study were within a normal ph range (5-7ph), and c.Starting from the 11 hour study and further, a progressive increase in ph reading above 8ph was noticed which continued to appear repetitively throughout the end of the study.The high ph readings can be noticed based on the blue lines which are presented on the graph due to the out of range ph measurements (above 8-9ph).The investigation identified the root cause of the reported event to be ph sensor of the capsule.If information is provided in the future, a supplemental report will be issued.
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