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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FERRITIN; FERRITIN IMMUNOLOGICAL TEST SYSTEM
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ROCHE DIAGNOSTICS ELECSYS FERRITIN; FERRITIN IMMUNOLOGICAL TEST SYSTEM Back to Search Results
Catalog Number 07027273190
Device Problems Low Test Results (2458); Non Reproducible Results (4029)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2024
Event Type  malfunction  
Event Description
The initial reporter complained of a discrepant low result for 1 patient sample tested for elecsys ferritin (ferritin) on a cobas e 801 analytical unit.The initial result was 2.07 ug/l.The initial result was not believed and the sample was repeated.The repeat result was 278 ug/l.This result was believed to be correct.
 
Manufacturer Narrative
The e801 analyzer serial number was (b)(6).
 
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Brand Name
ELECSYS FERRITIN
Type of Device
FERRITIN IMMUNOLOGICAL TEST SYSTEM
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhofer strasse 116
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
amy nelson
9115 hague road
indianapolis, IN 46250
MDR Report Key19003604
MDR Text Key339065171
Report Number1823260-2024-00954
Device Sequence Number1
Product Code JMG
UDI-Device Identifier04015630939688
UDI-Public04015630939688
Combination Product (y/n)Y
Reporter Country CodeNL
PMA/PMN Number
K971833
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
Report Date 03/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number07027273190
Device Lot Number76245601
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/07/2024
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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