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 RUBELLA IGG IMMUNOASSAY; ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
  • 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 RUBELLA IGG IMMUNOASSAY; ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA Back to Search Results
Model Number RUBELLA IGG
Device Problem False Positive Result (1227)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/06/2019
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).The samples were requested for investigation.
 
Event Description
The initial reporter complained of false positive results for 4 patient samples tested for elecsys rubella igg immunoassay (rubella igg) on a cobas 8000 e 602 module compared to the vidas method.The positive results were reported outside of the laboratory.The e602 module serial number was (b)(4).
 
Manufacturer Narrative
No patient samples were submitted for investigation.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 RUBELLA IGG IMMUNOASSAY
Type of Device
ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key9785788
MDR Text Key205338281
Report Number1823260-2020-00622
Device Sequence Number1
Product Code LFX
Combination Product (y/n)N
PMA/PMN Number
K072617
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 04/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRUBELLA IGG
Device Catalogue Number04618793190
Device Lot Number419075
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/12/2020
Initial Date FDA Received03/04/2020
Supplement Dates Manufacturer Received02/12/2020
Supplement Dates FDA Received04/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-