Model Number 256066 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/30/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b(4).Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
|
|
Event Description
|
It was reported that while using bd veritor plus analyzer with multiple lots of bd rapid detection of sars-cov-2 veritor¿ it shows a positive result on every covid test performed.Tests were immediately placed in another reader and results were negatives.No other confirmatory tests were performed.The customer stated the patients tested were asymptomatic.This test is not intended for use on asymptomatic patients and was therefore used off label.Results were not reported and there was no report of patient impact.Eua # (b)(4).
|
|
Manufacturer Narrative
|
The following field has been updated with corrected information: d.1 medical device type: qkp.
|
|
Event Description
|
It was reported that while using bd veritor plus analyzer with multiple lots of bd rapid detection of sars-cov-2 veritor¿ it shows a positive result on every covid test performed.Tests were immediately placed in another reader and results were negatives.No other confirmatory tests were performed.The customer stated the patients tested were asymptomatic.This test is not intended for use on asymptomatic patients and was therefore used off label.Results were not reported and there was no report of patient impact.Eua # (b)(4).
|
|
Manufacturer Narrative
|
The following field was updated with corrected information: d.1.Medical device brand name: bd rapid detection of sars-cov-2 veritor¿.
|
|
Event Description
|
It was reported that while using bd veritor plus analyzer with multiple lots of bd rapid detection of sars-cov-2 veritor¿ it shows a positive result on every covid test performed.Tests were immediately placed in another reader and results were negatives.No other confirmatory tests were performed.The customer stated the patients tested were asymptomatic.This test is not intended for use on asymptomatic patients and was therefore used off label.Results were not reported and there was no report of patient impact.Eua # 201889.
|
|
Manufacturer Narrative
|
The following field was updated with corrected information: d.1 medical device type: jjq.
|
|
Event Description
|
It was reported that while using bd veritor plus analyzer with multiple lots of bd rapid detection of sars-cov-2 veritor¿ it shows a positive result on every covid test performed.Tests were immediately placed in another reader and results were negatives.No other confirmatory tests were performed.The customer stated the patients tested were asymptomatic.This test is not intended for use on asymptomatic patients and was therefore used off label.Results were not reported and there was no report of patient impact.Eua # (b)(4).
|
|
Manufacturer Narrative
|
Investigation: bd has received several customer complaints for false positive results, when using bd sars-cov-2 reagents for bd veritor¿ system.The current investigation concerns multiple lots of bd sars-cov-2 reagents for bd veritor¿ system.Bd takes a systematic approach to investigating false positive complaints that are received.This approach involves review of manufacturing batch history records, testing of retention samples, and testing of customer returned samples if applicable.The investigation did not find a root cause for the false positive results that were observed.Bd cannot confirm the complaint based on the investigation that was performed.A corrective and preventive action (capa#1878253) is already initiated to investigate the root cause and some mitigation actions are already being addressed.
|
|
Event Description
|
It was reported that while using bd veritor plus analyzer with multiple lots of bd rapid detection of sars-cov-2 veritor¿ it shows a positive result on every covid test performed.Tests were immediately placed in another reader and results were negatives.No other confirmatory tests were performed.The customer stated the patients tested were asymptomatic.This test is not intended for use on asymptomatic patients and was therefore used off label.Results were not reported and there was no report of patient impact.(b)(4).
|
|
Search Alerts/Recalls
|