BECTON DICKINSON & CO. (SPARKS) BD VERITOR PLUS ANALYZER; COLORIMETER, PHOTOMETER, SPECTROPHOTOMETER
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Catalog Number 256066 |
Device Problem
False Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/20/2023 |
Event Type
malfunction
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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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Report 6 of 6.It was reported when using the bd veritor plus analyzer, false negative results for rsv were received.The rsv results were confirmed to be positive by pcr testing.There was no report of patient impact.
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Event Description
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Report 6 of 6.It was reported when using the bd veritor plus analyzer, false negative results for rsv were received.The rsv results were confirmed to be positive by pcr testing.There was no report of patient impact.
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Manufacturer Narrative
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H.6.Investigation summary: the complaint alleges the bd veritor plus analyzer provides discrepant results (catalog number 256066, serial number (b)(6).The customer said that the analyzer results showed as positive but visually the line showed positive.The results have been confirmed as positive by pcr.Issue has occurred with 6 patient samples.Customer was asked to insert the verification cartridge while on the phone and it passed.Customer is using walk-away mode on the analyzer.The discrepancies have occurred with the rsv test kit, multiple lots.The rma label was created to returned the defective unit, however, bd has not received the sample to be investigated.The complaint is unconfirmed.Dhr for veritor plus analyzer, serial number (b)(6) was reviewed and nonconformances related to this failure mode were not revealed in manufacturing during final testing.The device was released conforming.Review of risk management files confirms there are no new or modified risks associated with this failure mode.Bd quality will continue to monitor for trends associated with the failure mode described in this complaint.
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Search Alerts/Recalls
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