Model Number FHC-101-OBC517 |
Device Problems
False Negative Result (1225); 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 12/03/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Patient a which is reported under separate medwatch manufacturer report # 2027969-2015-01021.Investigation/conclusion: the customer's observation was not replicated in-house with retention devices.The retention devices were tested with 3 high level of hcg urine controls (201.4 iu/ml, 204.2 iu/ml and 212.2 iu/ml); all results were hcg positive at read time and no false negatives were obtained.Manufacturing batch record review did not uncover any abnormalities.The root cause could not be determined without patient specimen in-house analysis and specific information provided.Based on the information available, there is no indication of a product deficiency and no corrective action is required.
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Event Description
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Customer reported potential false negative hcg results using the consult hcg dipstick test 5000 pregnancy tests on 2 different patients.Patient b presented to office on (b)(6) 2015 with a positive home test.The first morning urine was tested and the urine was clear with normal smell.The patient was not taking any medications and had no health issues.The test line was ambiguous and called negative by 3 other staff.There was a strong control line presents.Ultrasound follow-up showed pregnancy of 9.5 weeks.A repeat of same sample was still negative.The result on the consult test was not used.Patient received routine pregnancy care.There was no blood test performed.There was no samples or product available for further investigation.Product: there was no abnormalities with product received, storage, procedure and the external qc record is complete.There was no adverse patient sequela.There was no additional information provided.Patient a submitted on separate medwatch form.
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Search Alerts/Recalls
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