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

Catalog Number 05031656190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/26/2015

Event Type  malfunction  

Event Description

The customer questioned the anti-ccp result of 57.49 u/ml for this sample, tested on (b)(6) 2015, because there was a large difference between this result and the patient's result of 11300 u/ml from "last summer".It is not known if erroneous results were reported outside of the laboratory.The sample was tested undiluted and diluted.The anti-ccp result from the undiluted sample was 56.74 u/ml.The sample was then diluted with an anti-ccp negative serum pool and tested using multiple dilution.A 2- fold dilution of the sample gave a result of 80.37 u/ml.The sample was repeated with 5-fold dilution and the result was 131.0 u/ml.The sample was repeated with 10-fold dilution and the result was >132.5 u/ml.The sample was repeated with 20-fold dilution and the result was >132.5 u/ml.The sample was repeated with 50-fold dilution and the result was 120.8 u/ml.The sample was repeated with a 100-fold dilution and the result was 72.53 u/ml.No adverse event was reported.The elecsys modular e170 serial number was not provided.Two samples from the patient were sent in for investigation.The results could not be reproduced.A specific root cause could not be identified during the investigation.A general reagent lot issue can be excluded.Product labeling documents autoantibodies are heterogeneous and this can cause non-linear dilution phenomena for certain individual samples.In addition, a sample dilution was not necessary as the result was within the measuring range.Recommended dilution is 1:2 to 1:5.The sample was diluted up to 1:100.

Manufacturer Narrative

This event occurred in (b)(6).

• Brand Name: ANTI-CCP
• Type of Device: ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 4712109
• MDR Text Key: 21187387
• Report Number: 1823260-2015-03148
• Device Sequence Number: 1
• Product Code: NHX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Health Professional
• Type of Report: Initial
• Report Date: 04/21/2015

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 Number: 05031656190
• Device Lot Number: 180711
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 04/21/2015
• 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
• Patient Age: 081 YR