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

Catalog Number	07251670190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number is (b)(6).Qc was acceptable.The customer repeated 5 other patient samples for troubleshooting purposes and the results were reproducible.The investigation is ongoing.H3 other text : na.
Event or Problem Description
The initial reporter complained of a discrepant low result for 1 patient sample tested for elecsys anti-ccp (anti-ccp) on a cobas e 801 analytical unit.The initial result was 14.4 u/ml.This result was reported outside of the laboratory where it was questioned by the patient.On (b)(6) 2023 the sample was repeated with results of 23.6 u/ml, 21 u/ml, and 20.8 u/ml.On (b)(6) 2023 the sample was repeated in the morning with a result of 30.2 u/ml.The sample was repeated later that afternoon with a result of 23.7 u/ml.All of the repeat results were more consistent with the patient¿s clinical condition.
Additional Manufacturer Narrative
Calibration and qc were acceptable.Data from calibration and qc do not point to a general reagent or instrument issue.Sample quality issues were not identified from the camera images provided.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.
Additional Manufacturer Narrative
Additional anti-ccp repeat results were provided from the sample obtained on (b)(6) 2023: 18 u/ml, 17.2 u/ml and 17.1 u/ml.On (b)(6) 2023 the patient had an anti-ccp result of 30.54 u/ml.The sample from (b)(6) 2023 was repeated with a result of 0.8 u/ml.The low results are in question.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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17145818
• Report Number: 1823260-2023-02013
• Device Sequence Number: 17578807
• Product Code: NHX
• UDI-Device Identifier: 04015630940370
• UDI-Public: 04015630940370
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 09/08/2023

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: 09/30/2023
• Device Catalogue Number: 07251670190
• Device Lot Number: 660228
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2023
• Supplement Date Received by Manufacturer: 07/19/2023; 08/28/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 07/25/2023; 09/08/2023
• 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: LEFLUNOMIDE.
• Patient Age: 24 YR
• Patient Sex: Female