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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS T4 ELECSYS E2G 300 V2; TOTAL THYROXINE ASSAY
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ROCHE DIAGNOSTICS T4 ELECSYS E2G 300 V2; TOTAL THYROXINE ASSAY Back to Search Results
Catalog Number 09007741190
Device Problems Display or Visual Feedback Problem (1184); Non Reproducible Results (4029)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2022
Event Type  malfunction  
Manufacturer Narrative
The investigation is ongoing.Na.
 
Event Description
The initial reporter received a questionable t4 elecsys e2g 300 v2 result for one patient sample tested on a cobas e411 rack with serial number: (b)(4) compared to a vidas analyzer.The initial result was not reported outside of the laboratory.The result from the e 411 at 1:51 pm was 246.5 nmol/l with a data flag.The result from the vidas analyzer at 2:00 pm was 130.96 nmol/l.The vidas result was reportedly more consistent with the total thyroid profile of the patient.
 
Manufacturer Narrative
The investigation is ongoing.Na.
 
Event Description
The initial reporter received a questionable t4 elecsys e2g 300 v2 result for one patient sample tested on a cobas e411 rack with serial number: (b)(4) compared to a vidas analyzer.The initial result was not reported outside of the laboratory.The result from the e 411 at 1:51 pm was 246.5 nmol/l with a data flag.The result from the vidas analyzer at 2:00 pm was 130.96 nmol/l.The vidas result was reportedly more consistent with the total thyroid profile of the patient.
 
Manufacturer Narrative
Additional information was requested but not provided.The cause of the event could not be dertermined.
 
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Brand Name
T4 ELECSYS E2G 300 V2
Type of Device
TOTAL THYROXINE ASSAY
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key13569155
MDR Text Key285991219
Report Number1823260-2022-00467
Device Sequence Number1
Product Code CDX
UDI-Device Identifier07613336171660
UDI-Public07613336171660
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/29/2022
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 Expiration Date06/30/2022
Device Catalogue Number09007741190
Device Lot Number53112600
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/29/2022
Initial Date FDA Received02/21/2022
Supplement Dates Manufacturer Received06/08/2022
Supplement Dates FDA Received06/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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