MAUDE Adverse Event Report: ROCHE DIAGNOSTICS RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS; ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Catalog Number 04618793190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer reported that they received erroneous results for one patient sample tested for igg antibodies to rubella virus (rubigg).The sample resulted as >2500 iu/ml on an e411 analyzer.The sample was diluted 1:20 and repeated on the e411 analyzer, resulting as 3541 iu/ml (positive).The positive result was reported to the patient and the doctor advised the patient to return after 2 weeks for a re-test.A second sample from the patient was tested on the e411 analyzer on (b)(6) 2016, resulting as 6.06 iu/ml (negative).The original sample was repeated again on the e411 analyzer on (b)(6) 2016, resulting as 4398 iu/ml accompanied by a data flag.The original sample was also repeated on an architect analyzer, resulting as 75.2 iu/ml (reactive) on (b)(6) 2016.The second sample was repeated again on the e411 analyzer on (b)(6) 2016, resulting as 5.57 iu/ml (negative).The second sample was also repeated on an architect analyzer, resulting as 5.4 iu/ml (grayzone) on (b)(6) 2016.The patient was not adversely affected.The serial number of the e411 analyzer was asked for, but not provided.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.Investigations have determined that there was no evidence of a malfunction of either the rubigg assay or with the analyzer.Based on the information provided, a sample mismatch is very likely.

• Brand Name: RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• 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: 5660352
• MDR Text Key: 45322553
• Report Number: 1823260-2016-00645
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K072617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 04618793190
• Device Lot Number: 189899
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2016
• 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