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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 04491785190
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2023
Event Type  malfunction  
Manufacturer Narrative
The customer used an expired dilution reagent for the first repeat result of the sample.Product labeling states "diluent universal 2 stability: unopened at 2-8 °c up to the stated expiration date.Stability: on the analyzers at t 20-25 °c 12 weeks." a new patient sample from (b)(6) 2023 is available and was requested for investigation.The investigation is ongoing.
 
Event Description
The initial reporter received a questionable elecsys ferritin result for one patient sample tested on the cobas 6000 e601 module serial number (b)(4).The initial result was reported outside of the laboratory.The reporter would like to understand the difference in ferritin results between the roche module's electrochemiluminescence immunoassay (eclia) method and an unspecified module's chemiluminescent immunoassay (clia) method used in the partner laboratory.The initial result from the module was 2000 ng/ml with a data flag.The first repeat result from the module with the patient sample at 1/100 dilution factor was 166119 ng/ml with a data flag.The second repeat result from the other module with the patient sample at a dilution factor of 1/5 factor was 8.250 ng/ml.
 
Manufacturer Narrative
The patient sample was received for investigation.The results reported by the customer were comparable with the results obtained by the investigation.The clinical chemistry method for ferritin also detected a high ferritin value.No heterophilic antibodies seem to be present in this patient sample, as the results after the heterophilic blocking tube (hbt) treatment did not decrease.A general reagent issue can be excluded.The investigation is ongoing.
 
Manufacturer Narrative
The customer's last calibration performed on (b)(6) 2023 was acceptable.The customer's quality control results were within specifications.The provided patient sample was also tested by using a 1:50 dilution.Both methods, the elecsys as well as the clinical chemistry method for ferritin show values far above the measuring range and comparable to the results reported by the customer.The investigation could not identify a product problem.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.
 
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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
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM   68305
Manufacturer Contact
amy nelson
9115 hague road
na
indianapolis, IN 46250
3174767531
MDR Report Key16622718
MDR Text Key312302412
Report Number1823260-2023-00991
Device Sequence Number1
Product Code JMG
Combination Product (y/n)N
Reporter Country CodeBR
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,Followup,Followup
Report Date 06/29/2023
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 Date05/31/2023
Device Catalogue Number04491785190
Device Lot Number60072101
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/27/2023
Initial Date FDA Received03/27/2023
Supplement Dates Manufacturer Received05/09/2023
06/01/2023
Supplement Dates FDA Received06/02/2023
06/29/2023
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
Patient SexMale
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