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

Catalog Number 05031656190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.The event occurred in (b)(6).

Event Description

The initial reporter complained of questionable results for approximately 60 patients tested for elecsys anti-ccp on a cobas 6000 e 601 module serial number (b)(4) compared to a cobas e 411 immunoassay analyzer.The customer provided examples of anti-ccp results for 14 patient samples.Of the data provided, there were discrepant results for 13 patient samples.Refer to the attachment to the medwatch for all provided patient sample data.The results from the e 411 were consistent with the patients' clinical diagnosis.The discrepant results were reported outside of the laboratory.There was no allegation of an adverse event.

Manufacturer Narrative

The calibration data does not contain any abnormalities.Based on the provided data, a general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS ANTI-CCP IMMUNOASSAY
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8771670
• MDR Text Key: 150552179
• Report Number: 1823260-2019-02458
• Device Sequence Number: 1
• Product Code: NHX
• 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,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

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 Expiration Date: 09/30/2019
• Device Catalogue Number: 05031656190
• Device Lot Number: 389152
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 07/08/2019
• Supplement Dates FDA Received: 08/08/2019
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1