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

Catalog Number 05031656190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/17/2015

Event Type  malfunction  

Manufacturer Narrative

It was noted that the customer has tested the sample at a different site on another e411 analyzer and the result was similar to the initial anti- ccp result of 38.82 u/ml.The actual result was not provided.

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 1 patient sample tested for anti-ccp.The erroneous results were reported outside of the laboratory.The initial anti-ccp result was 38.82 u/ml.This result was reported outside of the laboratory.The sample was sent to 2 external laboratories where the result from a siemens immulite analyzer was 1.79 u/ml and the result from an abbott architect analyzer was 4.80 u/ml.The sample was also repeated on another e411 system where the result was 45.41 with a data flag.No adverse event was reported.The e411 system serial number was (b)(4).Preventative maintenance was last performed on 11/13/2014.During performance testing, the instrument was found to be out of specification by the field service engineer.Calibration was performed on 07/16/2015 when the reagent kit was loaded onto the system.The customer uses anti-ccp once a week and runs all samples every monday.It was noted that the customer uses biorad quality controls which do not have values for anti-ccp.The customer has set a range based on the values received over time and is using that range when running quality controls.The reagent kit was recalibrated on 08/21/2015 when the calibration signals seemed lower.After recalibrating, the signal dropped lower.The quality controls at this time were within the range set by the customer.It was noted that the calibration signals obtained by the customer were too low for both levels and calibration is not performed frequently enough based on manufacturer recommendations.

Manufacturer Narrative

Upon further investigation, various reagent and maintenance handling issues were discovered at the customer site.The customer is also using a control lot which is not specified for anti-ccp.

• 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) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5067028
• MDR Text Key: 26028322
• Report Number: 1823260-2015-04116
• Device Sequence Number: 1
• Product Code: NHX
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: Health Professional
• Report Date: 10/12/2015

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 Expiration Date: 11/29/2015
• Device Catalogue Number: 05031656190
• Device Lot Number: 185555
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 049 YR