Catalog Number FHC-102-KHS25 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/14/2014 |
Event Type
malfunction
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Event Description
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Caller alleged false negative hcg results using two different lot numbers.Results as follows: an office worker who is confirmed to be pregnant took hcg tests using two different boxes.Both tests came back negative after 5 minutes, but then showed positive after 10 minutes.Refer to mdr #2027969-2014-01084 for first lot number.
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Manufacturer Narrative
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Customer's observation was not replicated in-house with retention product.Retention product was tested with cutoff hcg urine controls and 3 high level hcg positive controls.All hcg results were positive at read time.No false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.Unable to determine root cause 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.This issue will be subject to tracking and trending.
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Search Alerts/Recalls
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