Catalog Number 7D2648 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2021 |
Event Type
malfunction
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Event Description
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The customer reported a (b)(6) result with the alere determine hiv ½ ag/ab combo test performed at (b)(6) on (b)(6) 2021.Confirmation testing was performed on an unknown sample and generated (b)(6) results.The customer reported that the patient was/is pregnant.There was no death or serious injury.The customer stated that the patient did experience stress.In addition, the customer requested that the ob panel be changed from ordering a (b)(6) screen to pcr.Although requested, additional information regarding if the patient received (b)(6) has not been provided.
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Manufacturer Narrative
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The investigation is still in progress.A supplemental report will be provided after completion.
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Manufacturer Narrative
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This supplemental report is being submitted to provide additional information.Additional information: additional information from the customer states that the patient did not receive any antiretroviral therapy (art).
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Manufacturer Narrative
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The required intake information to enable further investigation, such as the kit's lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints' trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.
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Search Alerts/Recalls
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