Model Number FHC-A102 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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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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It was reported that on an unspecified date (between (b)(6) 2019 to (b)(6) 2019) a confirmed false positive result occurred on the consult diagnostics hcg cassette.Confirmatory testing provided a negative result (confirmatory test method and exact result unable to be provided).No treatment was provided or delayed based on the false positive results.No adverse patient outcome reported.Troubleshooting occurred with a discussion of the issues and possible causes such as deviation in storage/handling and testing technique.
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Manufacturer Narrative
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Update to d4: udi number corrected.Investigation conclusion: retained and returned devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 3 minutes and all devices yielded the expected negative results.No false positive 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 either retention or returned product.Per the package insert, this test provides a presumptive diagnosis for pregnancy.A confirmed pregnancy 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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