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	10/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for 8 samples from the same patient tested with elecsys anti-ccp on a cobas e 801 analytical unit.The eighth sample was also tested on a second e 801 unit.The elecsys anti-ccp results were all high (reference range = < 17 u/ml), but the patient had no clinical symptoms.The first sample resulted in an anti-ccp value of 108 u/ml.The second sample resulted in an anti-ccp value of 193 u/ml on (b)(6) 2022.The third sample resulted in an anti-ccp value of 216 u/ml on (b)(6) 2022.The fourth sample resulted in an anti-ccp value of 185 u/ml on (b)(6) 2023.The fifth sample resulted in an anti-ccp value of 184 u/ml on (b)(6) 2023.The sixth sample resulted in an anti-ccp value of 172 u/ml on (b)(6) 2023.The seventh sample resulted in an anti-ccp value of 184 u/ml on (b)(6) 2023.The eighth sample initially resulted in an anti-ccp value of 162 u/ml on (b)(6) 2024.This sample was repeated on the same e 801 system, resulting in a value of 184 u/ml.It was also repeated on a second e 801 analyzer, resulting in a value of 187 u/ml.The patient was tested at three other hospitals using the euroimmun anti-ccp method and two unknown methods.Anti-ccp results for all other methods were negative.
Additional Manufacturer Narrative
The serial number of the e 801 analyzer is (b)(6).The serial number of the second e 801 analyzer was requested, but not provided.A sample from the patient was provided for investigation.An interfering factor against the streptavidin component of the elecsys anti-ccp assay was ruled out.The investigation is ongoing.
Additional Manufacturer Narrative
On (b)(6) 2022, the patient had an rf result of 11.3 iu/ml (negative).On (b)(6) 2023, the patient had an rf igg result of 1 u/ml (negative), an rf iga result of 1 u/ml (negative), and an rf igm result of 4 u/ml (negative).Investigations of the patient sample were able to rule out other heterophilic antibody interference.Further clarification of the observed discrepancies is not possible with available methods and the current state of the art.The investigation could not identify a product issue.

• 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: 19927573
• Report Number: 1823260-2024-02288
• Device Sequence Number: 15547351
• Product Code: NHX
• UDI-Device Identifier: 04015630940370
• UDI-Public: 04015630940370
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 09/18/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 07251670190
• Device Lot Number: ASKU
• 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: 07/12/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown