MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS RUBELLA IGG; ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Catalog Number 04618793190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

The cobas 6000 e601 module serial number was (b)(6).A sample from the patient was requested for investigation.

Event Description

There was an allegation of a questionable rubella igg elecsys from the cobas 6000 e601 module.The initial result was 108.2 iu/ml (reactive).The result from another laboratory using synlab on liason instrument was 6.8 iu/ml (negative).On 12-jan-2024, the same sample was repeated on the original analyzer and the result was 124 iu/ml (reactive).

Manufacturer Narrative

The customer¿s positive elecsys rubella igg result for the patient sample was reproducible.The mikrogen recomblot rubella igg was negative without any visible bands, therefore, the patient sample was clearly neutralizable, strongly indicating the presence of anti-rubella igg.The platelia rubella igg assay showed an indeterminate result at ~12 iu/ml.The investigation determined the sample was correctly positive for rubella igg.

• Brand Name: ELECSYS RUBELLA IGG
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18636170
• MDR Text Key: 334650425
• Report Number: 1823260-2024-00311
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: K072617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

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: 73976001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1