Model Number FHC-A102-OBC554 |
Device Problems
False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
Miscarriage (1962); No Consequences Or Impact To Patient (2199)
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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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Email received from distributor alleging false negative urine hcg.Patient took a pregnancy test at home with a positive result and received a false negative in the office.Patient had a miscarriage after the office visit and called back to advise the doctor of the incident.Patient did not require surgery or any hospitalization due to this incident.Although requested, no additional information provided.
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Manufacturer Narrative
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Investigation conclusion update: customer's observation was not replicated in-house with retention and return devices.Retention and return devices were tested with 20 miu/ml hcg urine control and 3 high level of hcg urine controls; all results were hcg positive at read time and met qc specification.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.Root cause could not be determined without patient specimen in-house analysis.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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