The distributer reported that a women's health facility had false negative results on the hcg urine cassette initially providing a lot number.For one patient, the result for four tests with one specimen was 2 false positive results and 2 negative results with a negative serum test result.Subsequent contact with the customer revealed that the customer could not actually identify which lot number was used when the inaccurate results were obtained.The customer was not willing to provide additional details but would send the product back.On 01/22/2020, lot numbers hcg9072026, hcg9040123, hcg9040084 were received.It is still unknown which lot was used at the time of the events.For this reason, one mdr will report this event.This mdr is associated with 2027969-2020-0009.
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Additional information: d4: actual lots unknown with these potential udi numbers (b)(4).D10: device returned 03/23/2020.G4: 03/30/2020.H3: yes.H6: method 4101.Results 213.Conclusions 67.Investigation conclusion: retained and returned devices from the reported lot number were tested with hcg-negative clinical urine samples and qc cut-off standards (20 miu/ml).The results were read at 3 minutes and all devices tested with hcg-negative samples yielded the expected negative results, while all devices tested with qc cut-off samples yielded the expected positive results.No false results were observed during in-house testing.The case details were reviewed along with the complaint history for the reported issue and no indications of a systemic issue were identified.Manufacturing batch record review did not uncover any relevant non-conformances and found that the lot met quality control specifications.Review of the risk management report for this product found that the reported issue is within the risk profile for this device; no new hazard has been identified.A root cause could not be determined from the available information as the reported issue was not replicated during testing of retention or returned product.Per the package insert, this test provides a presumptive diagnosis for pregnancy.A confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
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