Catalog Number 03P84-25 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2021 |
Event Type
malfunction
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Event Description
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On (b)(6) 2021, abbott point of care was contacted by a customer regarding i-stat crea cartridges that yielded a suspected discrepant creatinine result of 4.0 mg/dl on a patient.There was no patient information available at the time of this report.(b)(6).Test/collection times not provided.There are no injuries associated with this event.Patient medication was requested as it is suspected that patient may be taking hydroxyurea.I-stat results can be higher than normal with the use of hydroxyurea, a substance that is known to interfere with the i-stat creatinine assay.Refer to art: 714183-00 rev aa.At this time there is no reason to suspect a malfunction exists.The investigation is underway.
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Manufacturer Narrative
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Apoc incident # (b)(4).Apoc labeling will be evaluated during the investigation as pertaining to the event.
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Manufacturer Narrative
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Apoc incident: # (b)(4).The investigation was completed on 10-jan-2022.A review of the device history record confirmed the lot passed finished goods release criteria.Retained cartridge testing for the lot met the acceptance criteria found in q04.01.003 rev.Ag, appendix 1- product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.
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Event Description
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Na.
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Search Alerts/Recalls
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