Catalog Number 05168589190 |
Device Problem
Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The serial number of the cobas 8000 c702 module is (b)(6).The investigation is ongoing.
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Event Description
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The initial reporter stated they received discrepant results for one patient sample tested with crep2 (creatinine) on a cobas 8000 c702 module.The sample initially resulted in a creatinine value of 72 umol/l.The sample was then repeated using the creatinine jaffe method and the creatinine value was 169 umol/l.The sample was then diluted 1:3 and repeated using the original crep2 method and the creatinine value was 105 umol/l accompanied by a data flag.The 169 umol/l value was reported to the patient because it agreed with the patient's clinical picture.
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Manufacturer Narrative
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A sample from the patient was provided for investigation.Initial investigations of the patient sample were able to duplicate the results obtained by the customer.The patient was diagnosed with hydrocephalus, sepsis, insulin-dependent diabetes mellitus, and pneumonia.The complained patient sample had a high glucose concentration of 34.07 mmol/l.The patient's total protein level was not elevated.Medwatch field d10 (concomitant medications) has been updated.
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Manufacturer Narrative
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Further investigation testing was performed to rule out a potential interference.All tested parameters were within the normal range.A specific root cause could not be determined based on the provided information.No general product problem was found.
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Search Alerts/Recalls
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