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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-CCP; ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)

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ROCHE DIAGNOSTICS ELECSYS ANTI-CCP; ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) Back to Search Results
Catalog Number 07251670190
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2023
Event Type  malfunction  
Event Description
The initial reporter received a questionable elecsys anti-ccp (anti-ccp) result from one patient sample tested on the cobas e 801 analytical unit.The result was 169 u/ml.The reporter stated this result was discrepant with the clinical expectation (below 17 u/ml) and the anti-ccp igg enzyme-linked immunosorbent assay (elisa) result.The reporter postulates a possible interference with anti-streptavidin antibodies.
 
Manufacturer Narrative
The serial number of the customer's cobas e 801 analytical unit is (b)(6).The patient sample was received for investigation.The investigation is ongoing.
 
Manufacturer Narrative
The investigation tested the patient samples for elecsys anti-ccp; the investigation was able to reproduce the customer's results.The investigation tested the patient samples for peptide specificity and streptavidin (sa) interference using reagents with streptavidin and biotin interference-eliminating proteins (ieps).The investigation detected the presence of anti-streptavidin antibodies.The results strongly suggest that the underlying streptavidin interference in the patient samples led to the falsely elevated elecsys anti-ccp assay results.The investigation determined the event was caused by the interfering factor in the patient sample.Product labeling states "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation excluded a general product problem.
 
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Brand Name
ELECSYS ANTI-CCP
Type of Device
ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)
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 Key18542103
MDR Text Key333399638
Report Number1823260-2024-00177
Device Sequence Number1
Product Code NHX
UDI-Device Identifier04015630940370
UDI-Public04015630940370
Combination Product (y/n)Y
Reporter Country CodeGM
PMA/PMN Number
K081338
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 02/20/2024
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 Catalogue Number07251670190
Device Lot Number73686801
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/02/2024
Initial Date FDA Received01/19/2024
Supplement Dates Manufacturer Received02/02/2024
Supplement Dates FDA Received02/20/2024
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
Patient Age62 YR
Patient SexMale
Patient RaceWhite
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