Catalog Number 20767107322 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The serial number of the customer's cobas 6000 c501 (ul) v module 1 is (b)(6).The serial number of the customer's cobas 6000 c501 (ul) v module 2 is (b)(6).The investigation is ongoing.
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Event Description
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The initial reporter received questionable trigl triglycerides results from an estimated minimum of 50 patient samples tested on two cobas 6000 c501 (ul) v (module 1 and module 2).The reporter was able to provide one patient sample with discrepant results: the initial result was not reported outside of the laboratory.The reporter stated that the qc would not pass and there was a high number of patient sample results with an invalidating data flag or very low results, prompting the rerun of previous patient samples on their other c501 module.The reporter stated that they noticed the issue after service was performed on their deionized (di) water system.The initial result from module 1 was 153 mg/dl.The repeat result from module 2 was 212 mg/dl.The repeat result could not be determined as both analyzers were affected by the water source issue.
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Manufacturer Narrative
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Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) updated.The field service engineer (fse) inspected the module and determined the event was caused by resistivity high on the water system.The fse flushed the water system and recalibrated the assay.The customer performed qcs with acceptable results.The investigation noted that the customer¿s water system underwent maintenance activities before the event.Water requirements are within the customer¿s responsibility.The investigation determined the event was consistent with mishandling (customer's water system maintenance).The investigation did not identify a product problem.
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Search Alerts/Recalls
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