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

Catalog Number 04618793190

Device Problem High Test Results (2457)

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

Event Date 08/08/2015

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of false positive results for 1 patient tested for igg antibodies to rubella virus (rubella igg).The positive results were reported outside of the laboratory.The initial rubella igg result was 25.04 iu/ml.This result was reported outside of the laboratory.On (b)(6) 2015 the repeat results from an architect analyzer, were 3.6 iu/ml (negative) and 3.5 iu/ml (negative).No adverse event occurred.The e602 analyzer serial number was (b)(4).

Manufacturer Narrative

Calibration and quality controls from the customer were acceptable.The sample was submitted for investigation.The rubella igg recomblot from mikrogen and the patella rubella igg test were performed on this sample.A neutralization test was also performed.Based on the results of these tests, the sample is very likely positive for rubella igg.The customer's positive rubella igg results are regarded as correct.

• Brand Name: IGG ANTIBODIES TO RUBELLA VIRUS
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• 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: 5050730
• MDR Text Key: 24941049
• Report Number: 1823260-2015-04080
• 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: Followup
• Report Date: 10/29/2015

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: 04618793190
• Device Lot Number: 18592700
• 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: 09/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/29/2015
• 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: 016 YR