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

Catalog Number 07251670190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2023

Event Type  malfunction  

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 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.

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.

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
• 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; 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
• MDR Text Key: 317918308
• Report Number: 1823260-2023-02013
• Device Sequence Number: 1
• Product Code: NHX
• UDI-Device Identifier: 04015630940370
• UDI-Public: 04015630940370
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081338
• Number of Events Reported: 1
• 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: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/28/2023
• 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 Number: 1
• Treatment: LEFLUNOMIDE.
• Patient Age: 24 YR
• Patient Sex: Female