ALERE SAN DIEGO, INC. MEDLINE HCG PREGNANCY TEST CASSETTE (URINE); VISUAL, PREGNANCY HCG, PRESCRIPTION USE
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Model Number FHC-102 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Conclusion pending completion of investigation.H3 other text : although requested, product has not been received for investigation.
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Event Description
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The customer reported two faint positive results when testing a patient urine sample with the medline hcg pregnancy test cassette (urine).The patient was being tested prior to receiving an iud.The customer stated that the physician then used a test from a different box, however the result was not specified, and no additional information was provided.The customer expressed some uncertainty as the accuracy of the two faint positive results.The customer did not clarify whether the patient had received the iud, however the customer did state that no treatment was provided or withheld on the basis of the two faint positive results.No adverse events were reported.
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Event Description
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The customer reported two faint positive results when testing a patient urine sample with the medline hcg pregnancy test cassette (urine).The patient was being tested prior to receiving an iud.The customer stated that the physician then used a test from a different box, however the result was not specified, and no additional information was provided.The customer expressed some uncertainty as the accuracy of the two faint positive results.The customer did not clarify whether the patient had received the iud, however the customer did state that no treatment was provided or withheld on the basis of the two faint positive results.No adverse events were reported.
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Manufacturer Narrative
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D4 updated with expiration date.H4 updated with date of manufacture.H6 and h10 updated to reflect outcome of investigation.Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 3 and 4 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 retention product.Complaints are tracked and trended on a monthly basis.Per the package insert: ¿ very low levels of hcg (less than 50 miu/ml) are present in urine specimen shortly after implantation.However, because a significant number of first trimester pregnancies terminate for natural reasons, a test result that is weakly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later.¿ a number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hcg.Therefore, the presence of hcg in urine should not be used to diagnose pregnancy unless these conditions have been ruled out.¿ 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.H3 other text : although requested, product has not been received for investigation.
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