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 01/25/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter received a questionable elecsys anti-ccp immunoassay result for one patient tested on a cobas 6000 e 601 module.The initial result was reported outside the laboratory to a clinician.The clinician was alerted of the questionable result due to the result not matching the patient's clinical picture and rheumatoid factor results.The patient's serum sample was tested for confirmation.The patient¿s anti-ccp result with a plasma sample was "weak positive." the patient¿s anti-ccp result with a serum sample was "negative" (<7 iu/ml).The patient's serum result was determined correct.The e 601 module serial number is (b)(4).

Manufacturer Narrative

The customer's calibration and qc were acceptable.The investigation discovered patterns of discrepant results between serum and plasma samples from the same blood draw of a given patient: negative results or results below the cutoff value on serum samples and positive results on plasma samples.Also, the concentrations obtained from plasma samples are dependent on the reagent lots used for testing.Further investigations were conducted and the investigation could not identify the root cause.

• 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
• MDR Report Key: 10123507
• MDR Text Key: 203839254
• Report Number: 1823260-2020-01371
• Device Sequence Number: 1
• Product Code: NHX
• Combination Product (y/n): N
• PMA/PMN Number: K081338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• 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: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1