Catalog Number 08056668190 |
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 07/07/2023 |
Event Type
malfunction
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Event Description
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The initial reporter received questionable hba1c results from about 7 to 10 patient samples tested on the cobas pro c 503 analytical unit.The initial results were reported to the patients.The reporter stated that the results of the 7-10 samples were high - between 8-10%.The reporter stated that the patients alleged that they have a non-diabetic history and that they retested by themselves at other sites and the results were normal.
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Manufacturer Narrative
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The serial number of the customer's cobas pro c 503 analytical unit is (b)(6).The investigation is ongoing.
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Manufacturer Narrative
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The investigation reviewed the alarm trace.There were frequent "abnormal aspiration" alarms and multiple "std.E", "samp.S" calibration failures.These alarms point to maintenance/hardware performance issues.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.
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Search Alerts/Recalls
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