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: an investigation was performed on retention and returned products for the reported lot number.Manufacturing batch record review did not uncover any abnormalities.Retention products and returned were tested with negative clinical urine.Results were read at 3 minutes and all devices correctly yielded negative results with strong control lines.No false positives were observed.A root cause could not be determined based on the information provided.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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It was reported that a (b)(6) year old female presented to the medical center with a scheduled iud insertion appointment.An hcg urine cassette was administered with a false positive result.Confirmatory testing was done the same day on 4/10, resulted in serum quant=0.0mlu/ml.Due to the positive result, the iud was not inserted.The iud was rescheduled for 4/12-iud was inserted on this rescheduled date.No further patient information available.
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