Catalog Number 08057524190 |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2024 |
Event Type
malfunction
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Event Description
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There was an allegation of a suspected interference with the crep2 assay for 1 patient on a cobas c 503 analytical unit.The suspected interference is with herpes virus drugs (aciclovir and valaciclovir) and cialis (tadalafil) episodically.The serum creatinine result was 119 mol/l.The creatinine urine spot (not 24-hour urine) result was 21.705 mol/l.It was reported that the patient's result is typically low when measured in another laboratory.The values are not known but are most probably in the range of reference values.
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Manufacturer Narrative
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The analyzer serial number is (b)(6).The sample was requested for investigation, however, it is not available.The investigation is ongoing.
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Manufacturer Narrative
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Medwatch fields a2, d1-d4 g1, and g4 were updated.The investigation determined the use of acyclovir may lead to kidney damage in a certain percentage of patients taking this drug which may lead to higher creatinine values.There was no interference found with the crep2 assay and no product issue could be identified.
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Search Alerts/Recalls
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