Model Number 443985 |
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 07/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that while using kit bd max enteric viral panel 10 false negative results were obtained by the laboratory personnel.A retest was used to confirm the results as false negatives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "user re-test when he got double or triple pos results from max ebp+xebp and evp and the re-test results often changed to one pos.".
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Event Description
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It was reported that while using kit bd max enteric viral panel 10 false negative results were obtained by the laboratory personnel.A retest was used to confirm the results as false negatives.There was no indication that results were reported out and there was no report of patient impact.The following information was provided by the initial reporter: "user re-test when he got double or triple pos results from max ebp+xebp and evp and the re-test results often changed to one pos.".
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Manufacturer Narrative
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This mdr should be considered cancelled due to a change in reportability.The investigation found that this was a reader pressure issue.This event will result in the return of an error code to the user that will result in an interruption in the device.
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Search Alerts/Recalls
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