Catalog Number 09175431190 |
Device Problems
False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/14/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
An investigation is in progress.A follow-up report will be filed upon the completion of the investigation.Facility name truncated due to character limit : (b)(6) laboratory.
|
|
Event Description
|
In light of the covid-19 pandemic and the subsequent emergency use authorizations (euas) for sars-cov-2 diagnostic tests, the agency has requested heightened reporting beyond the reasonably suggests requirements of 803 to include allegations of false positive or false negative results independent of harm or malfunction or off-label use.Pursuant to the agency¿s instruction, we hereby submit this mdr.A customer from japan alleged a discrepant sars-cov-2 result for a single patient while using the cobas sars-cov-2 qualitative nucleic acid test for use on the cobas 6800/8800 systems.The alleged sample initially generated sars-cov-2 negative results when tested on both cobas 6800 and cobas 8800 systems.A separate nasal sample was collected on a different day from the same patient and tested on another platform (abbott id now) which yielded a sars-cov-2 positive result.It is unknown if the results were reported.No harm or injury is indicated.An investigation has been initiated and is ongoing.Per fda¿s eua guidance, 1 mdr will be filed.
|
|
Manufacturer Narrative
|
The discrepancies observed were related to the difference in technologies and sample types.Data could not be provided by the customer for investigation.No lot information has been provided.Based on what the customer stated, the discrepancies observed are sample-specific.The discrepancies observed are likely a result of 2 different sample types being collected on different days and tested on different platforms.The negative result was reproducible on the cobas systems.It is likely, based on the information provided, that the patient has a low-level infection and the samples collected are at or near the limit of detection.Updated a code from false negative result to non reproducible results.
|
|
Search Alerts/Recalls
|