Catalog Number 340991 |
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 10/31/2023 |
Event Type
malfunction
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Event Description
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It was reported that after using bd stem cell control kit 15 tests ivd erroneous results were acquired.The following information was provided by the initial reporter: abnormally high blood cell count.A new lot of 340991 was measured and was far off the median value on the spec sheet and did not enter the reference value.We tried multiple times with different measurers and equipment, but the value remained high.1.Are there erroneous results on patient samples from diagnostic test? yes 2.Was there any delay of treatment due to the issue? no 3.If patient samples were redrawn, was there any change or delay of treatment? no 4.Was there any physical harm/injury to the patient due to the issue? no.
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Manufacturer Narrative
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H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that after using bd stem cell control kit 15 tests ivd erroneous results were acquired.The following information was provided by the initial reporter: abnormally high blood cell count.A new lot of 340991 was measured and was far off the median value on the spec sheet and did not enter the reference value.We tried multiple times with different measurers and equipment, but the value remained high.1.Are there erroneous results on patient samples from diagnostic test? yes.2.Was there any delay of treatment due to the issue? no.3.If patient samples were redrawn, was there any change or delay of treatment? no.4.Was there any physical harm/injury to the patient due to the issue? no.
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Manufacturer Narrative
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The following fields have been updated with corrected and/or additional information: reporting office: becton dickinson and company bd biosciences.Reporting office contact: (b)(6) - mdr.Manufacturing site contact: (b)(6) - mdr.Based on the investigation results, the reported issue of high cell counts was confirmed.Investigation results that were obtained regarding the indicated failure mode were the following: user data were returned including results of analysis showing customer calculations.Documentation for part lot 340991-bc1123 was reviewed and met specifications prior to release.The supplier investigation discovered customer miscalculation that accounted for results above expected values.Based on the investigation results, the reported issue of high cell counts was confirmed.The issue was resolved by providing customer with a replacement lot.The replacement lot resolved the reported issue of the customer complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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