Customer reported that a pt presented at the user facility on 12/19/1997 with abdominal pains.
An icon hcg test for pregnancy was performed on the pts serum with negative results.
All controls performed as expected.
The pt was then given x-rays of the chest, kidneys, ureter and bladder.
The x-rays did not identify a cause of the abdominal pain.
On 1/3/98 the pt was given an ultrasound and a fetus of approx 5 weeks was identified.
No pt sample was available for further testing.
Pt indicated that her last menses was 11/28/97.
The icon hcg kit instructions indicate that the sensitivity for serum sample is 10mlu/ml and in most cases elevated hcg will be detected in the first week after implantation or 4-5 days before a missed menses.
Estimated missed menses for this pt would be approx 12/27/97.
Based on currently available info, it appears that the hcg levels may have been below 10 mlu/ml on 12/19/97.
If this is the case, then icon hcg test kit performed according to labeled claims.
Labeling also states that when a negative result is obtained and pregnancy is suspected, a second icno hcg test should be performed on a new sample 48 hours or more after the initial test.
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