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Model Number FHC-102 |
Device Problem
False Negative Result (1225)
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Patient Problem
Hormonal Imbalance (4495)
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Event Date 03/09/2023 |
Event Type
Injury
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Manufacturer Narrative
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Investigation conclusion: retained devices from the reported lot number were tested with qc cut-off positive controls (25 miu/ml) and high-hcg clinical urine samples (202.7¿222.9 iu/ml).The results were read at 3 minutes and all devices yielded the expected positive results.No false negative 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.Complaints are tracked and trended on a monthly basis.Per the package insert: ¿ very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hcg.If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.¿ false negative results may occur when the levels of hcg are below the sensitivity level of the test.When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.H3 other text : the customer did not elect to return devices for investigation.
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Event Description
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The distributor reported an unspecified number of false negative results when testing patient samples using the hcg cassette rapid test, but was only able to provide information for one patient.The patient was tested as a screen prior to receiving a depo-provera injection for contraception.The patient tested negative on the hcg cassette rapid test and received the depo-provera injection.An unspecified urine pregnancy test was performed at another clinic 26 days later with a positive result.A quantitative blood hcg test was performed the following day with a result of 41,863 (units not specified), and the patient was diagnosed as pregnant.The patient's progesterone was determined to be low (5.8, units not specified); the patient was prescribed 200 mg progesterone per day.
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Search Alerts/Recalls
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