Investigation conclusion: retained devices from the reported lot number were tested with hcg-negative clinical urine samples.The results were read at 5 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.Review of the information provided did not identify any evidence of misuse.The customer was unsure of the volume used on the test, but the technician couldn't retest sample because of insufficient sample.There were no other indications that the user deviated from the package insert.The minimum detect level for this product is 5miu/ml.The hcg concentration of the patient sample from the reported complaint was 8.0 miu/ml, which is above the minimum detect level.Therefore, positive results may be observed at this concentration.
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