Model Number FHC-101 |
Device Problem
False Negative Result (1225)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 10/25/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation conclusion: investigation pending.
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Event Description
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Report received of false negative urine hcg results received on consult hcg dipstick test 5000 25t.Patient's lmp: 2 months prior to the test.Patient was having early pregnancy signs and had 3 home tests (unknown product) all results were positive.On (b)(6) 2016 hcg results on consult hcg dipstick test provided negative hcg results; repeat hcg test was also negative.Serum quant: initial serum result on (b)(6) 2016 hcg negative (cut-off unknown), follow-up on (b)(6) 2016 hcg was 14725 miu/ml.No procedure/treatment performed based on discrepant results.Current status of patient is normal pregnancy.No reported adverse patient sequela.
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Manufacturer Narrative
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Investigation/conclusion: the customer's observation was not replicated in-house with retention products of the reported lot.Retention devices were tested in-house with 25 miu/ml hcg urine cutoff controls and 3 high-level hcg urine controls.All results were hcg-positive at the read time and met the qc specification.False negative results were not observed during in-house investigation.A review of manufacturing batch records did not uncover any abnormalities.A root cause could not be determined from the information provided by the customer.Based on the information available, there is no indication of a product deficiency.No corrective action is required at this time.
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Search Alerts/Recalls
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