Model Number FHC-A202-OBW515 |
Device Problem
False Negative Result (1225)
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Patient Problems
Misdiagnosis (2159); Patient Problem/Medical Problem (2688)
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Event Date 04/19/2016 |
Event Type
Injury
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Manufacturer Narrative
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Investigation conclusion: customer's observation was not replicated in-house with retention devices.Retention devices were tested with 10 miu/ml hcg cutoff serum control and 100 miu/ml serum control; 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.The root cause could not be determined based on the information provided by the customer and 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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Event Description
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Report of false negative serum hcg results on cardinal health rapid test hcg combo.Patient's lmp: (b)(6) 2016.Customer called in stating that on (b)(6) 2016 patient came in and tested negative for hcg at their facility.Three days later the patient underwent a procedure to remove a skin lesion.Patient was given kenalog lidocaine for the procedure.Location of lesion not provided.On (b)(6) 2016 patient was determined to be (b)(6) pregnant via ultra sound and had been roughly (b)(6) pregnant for the procedure.Patient reported to have a history of miscarriage.Patient's pregnancy is being monitored by physician.
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Search Alerts/Recalls
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