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

Catalog Number 04618793190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2015

Event Type  malfunction  

Event Description

The customer received questionable rubella igg (igg antibodies to rubella virus) results for one patient sample from cobas e602 analyzer serial number (b)(6).The initial result was 4.50 iu/ml (negative).The repeat result on (b)(6) 2015 was 4.53 iu/ml (negative).The same sample was tested on a vidas analyzer and the result was 20 (positive).No unit of measure was provided.The same sample was tested in another laboratory, possibly on a liaison instrument and the result was 14.3 (positive).No unit of measure was provided.The result of 4.53 iu/ml was reported outside the laboratory.The patient was not adversely affected.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

The customer received a questionable rubella igg (igg antibodies to rubella virus) result for a second patient sample.On (b)(6) 2015, the initial results were 9.28 iu/ml and 9.46 iu/ml (negative).The results on a vida analyzer were 35 and 36.No unit of measure was provided.The result of 9.28 was reported outside the laboratory.The patient was not adversely affected.The patient's rubella igm was negative.The patient was (b)(6) female.

Manufacturer Narrative

As part of further investigation, recomblot rubella (mikrogen) testing performed on both samples was positive.Based on these results and the results provided by the customer, the samples were considered to be truly reactive.The provided calibration and qc results were all within expected ranges.

Manufacturer Narrative

Samples from the two patients were submitted for investigation and the customer's results were reproduced.

• 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: 4943855
• MDR Text Key: 6038797
• Report Number: 1823260-2015-03870
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: LU
• PMA/PMN Number: K072617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2015

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: 182963
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 07/13/2015
• Initial Date FDA Received: 07/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/04/2015
• 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
• Patient Sequence Number: 1
• Patient Age: 019 YR