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 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

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Event Description

The customer received questionable results for elecsys rubella igg immunoassay when they changed lot numbers of reagents.The lab switched from lot 206194 to 267421 and noticed that some patients which were slightly positive at 14-15 iu/ml with the old lot had negative results with the new lot.Specific patient data was requested but was not provided.The erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The customer used a cobas 8000 e 602 module.The serial number was requested but was not provided.

Manufacturer Narrative

A specific root cause could not be identified.Biweekly maintenance was performed, the pinch valve tubing was changed, and repeatability testing was performed.The calibration and qc data was acceptable.Differences in rubella igg results may occur at all concentration levels, but are more prominent for values close to cut off.Both involved reagent lots performed within specification and the differences may be related to precision and lot-to-lot variability.

• 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: 7132965
• MDR Text Key: 96032126
• Report Number: 1823260-2017-03045
• 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: 01/11/2018

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: 12/12/2017
• Initial Date FDA Received: 12/20/2017
• Supplement Dates Manufacturer Received: 12/12/2017
• Supplement Dates FDA Received: 01/11/2018
• 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