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

Catalog Number 05031656190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

The customer provided 3 patient samples for further investigation.It was not clear if these 3 patients were new patients or previously mentioned patients.The investigators measured the 3 patient samples with reagent lots 358539 and 389152.Anti-ccp results from reagent lot 358539: patient 5 10.1 u/ml, patient 6 < 7 u/ml, patient 7 9.03 u/ml.Anti-ccp results from reagent lot 389152: patient 5 19.4 u/ml, patient 6 24.2 u/ml, patient 7 23.2 u/ml, all results were above the anti-ccp cutoff of 17 u/ml.Further investigations have shown that there are lot to lot discrepancies, but the specific root cause for the lot to lot discrepancies are still being investigated.(b)(6).

Event Description

The initial reporter complained of questionable results for multiple patients when they switched to new lots of elecsys anti-ccp immunoassay reagent.Testing was performed on a cobas 6000 e 601 module.The customer stated that when they switched to new reagent lots 368033 and 389152 almost all the results were increased even in healthy patients.Control results would be acceptable.In one experiment, the customer performed anti-ccp comparison testing for 4 patients between serum tube samples and lithium-heparin plasma tube samples.Serum results from lot 389152: patient 1 7 u/ml, patient 2 7 u/ml, patient 3 7 u/ml, patient 4 8 u/ml (7 u/ml on (b)(6) 2019).Plasma results from lot 389152: patient 1 61 u/ml (58 u/ml on (b)(6) 2019); patient 2 59 u/ml (57 u/ml on (b)(6) 2019); patient 3 50 u/ml (48 u/ml on (b)(6) 2019); patient 4 63 u/ml (63 u/ml and 62 u/ml on (b)(6) 2019).The serum tube results were as expected but the plasma results were high and did not fit the patient's clinical pictures.In another experiment, the customer stated that "4" patient plasma samples were tested with reagent lots 368033 and 3891552 and compared to another laboratory using reagent lot 358539.The specific date of testing was not provided.The reagent lot 368033 results were 37 u/ml and 38 u/ml.The reagent lot 389152 results were 31 u/ml and 26 u/ml.The other laboratory result from reagent lot 358539 was < 7.0 u/ml.It was not clear the total number of patient results affected.It was not clear if both "experiments" involved the same patients or different patients.The results in question were reported outside of the laboratory.There was no allegation of an adverse event.The cobas e601 serial number was (b)(4).

Manufacturer Narrative

The following information has been communicated to roche customers: roche has confirmed performance issues with certain lots of the elecsys anti-ccp assay on the cobas e 411 analyzer; modular analytics e 170 module; and cobas e 601, 602, and 801 modules with plasma samples.The following customer observations have been reported: 1.Discrepant results between serum and plasma samples from the same blood draw of a given patient: negative results (< cutoff) on serum and positive results on plasma samples.2.Discrepant concentrations obtained on plasma samples when comparing different reagent lots.Serum samples are not affected and do not require a workaround.It is strongly advised to use the elecsys anti-ccp assay with serum samples only for the affected lots.Roche is conducting an investigation into the reported issue and has determined that the elecsys anti-ccp assay is strongly affected by pre-analytical errors.The investigation has reproduced these findings when requirements for pre-analytical sample handling have not been met for plasma samples.Therefore, we would like to emphasize the importance of following the pre-analytical sample handling recommendations when processing samples (serum and plasma).

• 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: 8771591
• MDR Text Key: 150551962
• Report Number: 1823260-2019-02454
• 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: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• 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
• Date Manufacturer Received: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1823260-07/16/19-007-C
• Patient Sequence Number: 1