Catalog Number 7D2648 |
Device Problem
False Positive Result (1227)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 11/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No kit, lot number was provided for a specific investigation.No sample was returned for further testing, and no additional information was provided.A review of complaint trends revealed that all of the alere determine hiv ½ ag/ab lots are performing according to label claims.The exact root cause of the reported issue could not be determined.The results obtained may possibly be related to the patient sample.The sample may have contained specific substances which may have affected the results.The available evidence suggests that the device is performing within labeled claims.
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Event Description
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A customer reported two (b)(6) results with the alere determine hiv 1/2 ag/ab combo.There is insufficient information to determine if a malfunction occurred.The exact number of patient or patients was not reported.The patient(s) gender, pregnancy status, treatment and patient outcome were unknown.No device lot number was provided.Attempts to gain additional patient information were not successful.
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Event Description
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(b)(6)2018 : additional information.Both patients were reported as male.The alere determine hiv 1/2 ag/ab combo test results were both positive for ag.The confirmatory negative testing was performed with an hiv 4th generation test.
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Manufacturer Narrative
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Risk of short- and medium-term toxicity to a non-pregnant female patient with the current recommended art prophylaxis regimens is primarily transient metabolic abnormalities which appears to be primarily mild and reversible after treatment is interrupted.The risk will not cause or contribute to a death or serious injury and is therefore considered not reportable.
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Search Alerts/Recalls
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