Catalog Number 256082 |
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 11/25/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
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.(b)(4).Medical device lot #: 0262358 was reported, however, this is not a lot# manufactured for this product #.
|
|
Event Description
|
It was reported while testing for sars cov-2 a false positive result was obtained.A repeat test was performed using pcr and the result was negative.The customer stated they are testing asymptomatic patients.This test is not intended for use on asymptomatic patients and was therefore used off label.The customer stated results were not reported out so there was no report of patient impact.Eua#: (b)(4).
|
|
Manufacturer Narrative
|
Eua#: (b)(4).H6: investigation summary: 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.Retain samples were tested for batch #: 0262358.The defect could not be replicated and therefore the complaint could not be confirmed.A device history review was conducted for lot number 0262358.The investigation did not find a root cause for the false positive results that were observed.It is recommended that each customer review their workflow carefully to ensure that the package insert is being followed as written.The root cause is under investigation and will be documented in our quality system.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 while testing for sars cov-2 a false positive result was obtained.A repeat test was performed using pcr and the result was negative.The customer stated they are testing asymptomatic patients.This test is not intended for use on asymptomatic patients and was therefore used off label.The customer stated results were not reported out so there was no report of patient impact.Eua#: (b)(4).
|
|
Search Alerts/Recalls
|