Model Number 256040 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2021 |
Event Type
Injury
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Event Description
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It was reported that while using kit grp a strep 30 test veritor false positive results were obtained by the laboratory personnel.The false results were reported out and the patient was treated based on this information.The following information was provided by the initial reporter: " p1.(b)(6) 2021 at 10:00 am fp.".
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.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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Manufacturer Narrative
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H6: investigation summary: this statement is to summarize the investigation results regarding your complaint that alleges discrepant results (1 sample false negative, and 7 samples false positive) when using kit grp a strep 30 test veritor (material #256040), batch number 1123931 and unidentified batch numbers.Bd quality performs a systematic approach to investigate discrepant results complaints.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples, if applicable.An investigation and testing were performed on the batch number provided.Returned product testing was completed and all devices had normal intended results.The reported issue was unable to be confirmed.The root cause could not be identified.No trend against discrepant results was identified.Currently no adverse trend for discrepant results was identified.Bd quality will continue to closely monitor for trends.
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Event Description
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It was reported that while using kit grp a strep 30 test veritor false positive results were obtained by the laboratory personnel.The false results were reported out and the patient was treated based on this information.The following information was provided by the initial reporter: "p1: (b)(6) 2021 at 10:00 am fp".
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Search Alerts/Recalls
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