Model Number FHC-A102 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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Results pending completion of the investigation.
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Event Description
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The distributor reported discrepancies with hcg results at a women's health center.There were false positive results with different lot numbers.For one patient, the result for four tests with one specimen was 2 false positive results and 2 negative results with a negative result for the serum test.Information regarding patient information and outcome, the circumstances surrounding the event, and product identifiers were requested but the customer was unwilling to provide the information.
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Manufacturer Narrative
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Additional information: 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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Manufacturer Narrative
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Additional information: d10: device availability changed from yes to no.Investigation conclusion: retained 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 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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Search Alerts/Recalls
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