At the time of the event, there was no indication of a reportable malfunction based on information provided and assessed by alere (b)(4).Alere (b)(4) updated reporting decisions and conducted a retrospective review of complaints against the updated reporting decisions.This mdr is a retrospective filing that was identified during this retrospective review activity associated with an observation from an fda inspection conducted in january 2019 at alere (b)(4) (reference eir (b)(4)).The awareness date is based on updated reporting decisions and completion of the retrospective review activity.There is no new or increased trend based on this retrospective review activity.Investigation results: retention devices for the reported lot were tested with clinical negative urine samples.All results were read at 3 minutes and yielded expected negative results.No false positive results were observed.Manufacturing batch records of the final-product, relevant product components, and quality control release data were reviewed.No relevant non-conformances, deviations, or abnormalities were found.All quality control specifications were met.Retention products performed as expected during in-house testing and could not replicate the reported complaint.This issue will be subject to tracking and trending.Deviations in testing procedure were identified during troubleshooting.Per the package insert, users should apply three drops of urine onto the mckesson consult diagnostics hcg urine cassette and a timer should be set to 3 minutes.This test provides a presumptive diagnosis for pregnancy.A false positive result can be caused by a variety of factors and interfering substances.Please refer to the limitations and interfering substances section of the package insert.For these reasons, a secondary analytical method must be used to obtain a confirmed result.
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