ALERE SAN DIEGO, INC. SURE-VUE SERUM/URINE HCG-STAT; VISUAL, PREGNANCY HCG, PRESCRIPTION USE
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Model Number FHC-A202 |
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 03/28/2024 |
Event Type
malfunction
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Event Description
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The customer also reported false positive results when testing urine and serum samples from one patient.The patient was being screened prior to a colonoscopy.The initial urine test yielded a faint test line and was interpreted as positive.The urine sample was retested, however the result was not specified.A serum sample was then collected and tested with the sure-vue serum/urine hcg-stat, yielding a similar faint positive result.Finally, a quantitative beta hcg test was performed with a result of 3 u/l, and the patient was determined not to be pregnant.The colonoscopy was delayed by approximately an hour and a half.No adverse outcomes were reported (h-10 for the related report number documenting the event above).The following day, the urine sample was tested with an alternate lot and yielded similar results.No adverse events were reported.
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Manufacturer Narrative
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Investigation conclusion: retained devices from the reported lot numbers were tested with hcg-negative clinical urine and serum samples.The results were read at 3 and 4 minutes for urine, and 5 and 6 minutes for serum, and all devices yielded the expected negative results.Retained devices were also tested with qc cut-off urine (20 miu/ml) and serum (10 miu/ml) samples.The results were read at 3 minutes for urine and 5 minutes for serum, and all devices yielded the expected positive results.All results met final release specifications for line intensity.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 lots 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 50miu/ml) are present in urine and serum 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 serum or urine specimen collected 48 hours later.A number of conditions other than pregnancy, including trophoblastic disease and certain nontrophoblastic neoplasms including testicular tumors, prostate cancer, breast cancer, and lung cancer, cause elevated levels of hcg.Therefore, the presence of hcg in serum or urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (hama) in the specimen.Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain hama.Such specimens may cause false positive or false negative results.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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