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

Catalog Number 04618793190

Device Problem Low Test Results (2458)

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

Event Date 01/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event occurred in: (b)(6).

Event Description

The customer complained of 4 patient samples that tested negative for elecsys rubella igg (roche igg) immunoassay on cobas e 411 immunoassay analyzer were confirmed positive by western blot testing.The customer was contacted by a separate laboratory about a patient who tested negative for rubella igg using a roche method who was testing positive in their laboratory.The customer took all the sera samples that were found to be negative since (b)(6) 2016 and sent them to another laboratory for testing using diasorin method.Of 5 patient samples that were found to be negative, 4 were confirmed as being initially reported as false negatives and are a reportable malfunction.No specific units were provided.The diasorin cutoff is 12 while the roche igg cutoff is 10.The siemens cutoff was not provided.Patient #1 had a roche igg result of 6 (negative), a diasorin result of 35 (positive), a siemens result of 18, and a positive western blot.Patient #2 had a roche igg result of 6 (negative), a diasorin result of 23 (positive), a siemens result of 23, and a positive western blot.Patient #3 had a roche igg result of 3 (negative), a diasorin result of 32 (positive), a siemens result of 13.7, and a positive western blot.Patient #4 had a roche igg result of 8 (negative), a diasorin result of <8 (negative), a siemens result of intermediate with an "ac anti-e1 positive", and a positive western blot.The patients were pregnant woman who all gave birth at the customer¿s hospital.No other patient information was provided.The erroneous results were reported outside of the laboratory.The results from the western blot testing were deemed to be correct.There was no allegation of an adverse event.The cobas e411 serial (b)(4).The investigation is still ongoing.

Manufacturer Narrative

As no sample material was available for further investigation, a specific root cause could not be determined.Additional information for further investigation was requested but was not provided.Product labeling for the assay documents single false negatives/positives can occur due to the sensitivity/specificity of the assay.

• 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: 7120689
• MDR Text Key: 95939291
• Report Number: 1823260-2017-02952
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

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: 04618793190
• Device Lot Number: 267421
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 11/30/2017
• Supplement Dates FDA Received: 01/04/2018
• 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