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

Catalog Number 05031656190

Device Problem High Test Results (2457)

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

Event Date 07/16/2015

Event Type  malfunction  

Manufacturer Narrative

The patient samples were not provided to complete the investigation.

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of erroneous results for 2 patient samples tested for anti-ccp.The erroneous results were reported outside of the laboratory.Patient 1 initial anti-ccp result was 128 u/ml.The repeat results from an abbott analyzer and a phadia analyzer were both "negative." the actual results were not provided.Patient 2 (female with (b)(6)) initial anti-ccp result was 188 u/ml.The repeat results from an abbott analyzer and a phadia analyzer were both "negative." the actual results were not provided.No adverse event was reported.The e602 analyzer serial number was (b)(4).A specific root cause could not be identified.Additional information for further investigation was requested but was not provided.

• 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: 5018159
• MDR Text Key: 24989517
• Report Number: 1823260-2015-03994
• Device Sequence Number: 1
• Product Code: NHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/02/2015

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: 183411
• 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: 08/20/2015
• 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: 045 YR