Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-SARS-COV-2; CORONAVIRUS SEROLOGICAL REAGENT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ROCHE DIAGNOSTICS ELECSYS ANTI-SARS-COV-2; CORONAVIRUS SEROLOGICAL REAGENT Back to Search Results
Catalog Number 09203095190
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/07/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation is ongoing.This event occurred in (b)(6).
 
Event Description
The initial reporter received questionable elecsys anti-sars-cov-2 results for 30 patients when compared to the abbott assay.The analyzer module and serial number were requested but not provided.Information regarding each patient's pcr result or time of testing is unknown.The initial reporter alleged 15 patients with discrepant negative results when compared to the abbott assay that produced positive results for the same samples.The initial reporter alleged 15 patients with discrepant positive results when compared to the abbott assay that produced negative results for the same samples.
 
Manufacturer Narrative
Based on the data provided, the investigation did not identify a product problem.The cause of the event could not be determined.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ELECSYS ANTI-SARS-COV-2
Type of Device
CORONAVIRUS SEROLOGICAL REAGENT
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key10273426
MDR Text Key199297604
Report Number1823260-2020-01693
Device Sequence Number1
Product Code QKO
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 08/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number09203095190
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received06/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-