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

Catalog Number	07251670190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys anti-ccp (anti-ccp) on a cobas e 801 analytical unit compared to a competitor method.The initial result from the e801 analyzer was > 500 u/ml.The sample was repeated by a competitor method (immunocap 250) and the result was 0.2 moc (reference range <1.0).On (b)(6) 2023 the customer repeated the original patient sample for confirmation on the e801 analyzer and the result was > 500 u/ml.
Additional Manufacturer Narrative
The sample was requested for investigation.
Additional Manufacturer Narrative
The sample was investigated further where an interference against the streptavidin component of the assay was identified.This interference caused the high anti-ccp results.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." the investigation did not identify a product problem.
Additional Manufacturer Narrative
Section b3 was updated.The customer's e801 analyzer serial number was (b)(6).The initial report stated: "the sample was repeated by a competitor method (immunocap 250) and the result was 0.2 moc (reference range: 1.0)." this should say: "on (b)(6) 2023 a new sample was obtained and tested by a competitor method (immunocap 250) and the result was 0.2 moc (reference range: 1.0)." the initial report stated: "on (b)(6) 2023 the customer repeated the original patient sample for confirmation on the e801 analyzer and the result was: 500 u/ml." this should say: "on (b)(6) 2023 the customer repeated the original patient sample for confirmation from the 'long-term serotheque' and the result was: 500 u/ml." the patient sample was received for investigation and tested with elecsys anti-ccp reagent lot 714474 on a cobas e 801 analytical unit.The customer's anti-ccp result was reproduced on the e801 analyzer at the investigation site (500 u/ml with a data flag).The sample underwent rheumafactor interference testing.The rheumatoid factor in the sample was below 14 iu/ml, and therefore within the normal range (4.8 iu/ml).Based on this result, the sample was further tested for iga, igm, and igg to check for a high immunoglobulin, however, all immunoglobulin testing was within the normal range: iga2 = 1.22 g/l.Igg2 = 11.04 g/l.Igm2 = 1.89 g/l.The investigation is ongoing.

• Brand Name: ELECSYS ANTI-CCP
• Common Device Name: 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 Key: 17896496
• Report Number: 1823260-2023-03226
• Device Sequence Number: 17921989
• Product Code: NHX
• UDI-Device Identifier: 04015630940370
• UDI-Public: 04015630940370
• Combination Product (Y/N): Y
• Initial Reporter Country: WZ
• PMA/510(K) Number: K081338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 07251670190
• Device Lot Number: 71447401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 10/30/2023; 11/29/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/20/2023; 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALMOGRAN; CONDROSULF 800; LAXOBERON; MACROGOL; METAMUCIL; MOVICOL
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Race: White