MAUDE Adverse Event Report: ROCHE DIAGNOSTICS RF-II RHEUMATOID FACTORS II; SYSTEM, TEST, RHEUMATOID FACTOR

Catalog Number 05480167190

Device Problem Low Test Results (2458)

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

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

The customer received questionable rf-ii rheumatoid factors ii results for one patient sample.The result from cobas 8000 c 702 module serial number (b)(4) was 39.8 iu/ml.The result from a au580 analyzer 1152 iu/ml.The results from a immage 800 analyzer was 750.0 iu/ml.The customer diluted the sample 1:5 and the result was 11.3 (56.5) iu/ml.No erroneous result was reported outside of the laboratory.There was no allegation of an adverse event.

Manufacturer Narrative

The investigation was unable to find a definitive root cause.As only one patient sample was affected and the result increased after dilution, an interference was suspected.The calibration and qc data was acceptable.

• Brand Name: RF-II RHEUMATOID FACTORS II
• Type of Device: SYSTEM, TEST, RHEUMATOID FACTOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7306819
• MDR Text Key: 101596470
• Report Number: 1823260-2018-00620
• Device Sequence Number: 1
• Product Code: DHR
• Combination Product (y/n): N
• PMA/PMN Number: K000534
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 05480167190
• Device Lot Number: 27266201
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "HORMONAL DRUGS"