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 12/20/2023

Event Type  malfunction  

Event Description

The initial reporter received questionable rubella igg elecsys results from one patient sample tested on the cobas 6000 e601 module.On (b)(6) 2023: the initial result of the patient's initial sample from the module was 52 ui/ml.On (b)(6) 2024: the result of the patient's new sample from the module was 51 ui/ml.The repeat result of the patient's initial sample from the abbott alinity was 5.2 (the unit of measurement was not provided).

Manufacturer Narrative

The serial number of the customer's cobas 6000 e601 module is (b)(6).The investigation is ongoing.

Manufacturer Narrative

Section d4, lot number, and expiration date were updated.The unit of measure for the abbott alinity result was iu/ml.The patient sample was not available for investigation.The investigation reviewed the last calibration performed on 11-jan-2024; the results were within specifications.The investigation reviewed the qc recoveries; the results were within specifications before the event.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 18639050
• MDR Text Key: 334501379
• Report Number: 1823260-2024-00317
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): Y
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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 Expiration Date: 06/30/2024
• Device Catalogue Number: 04618793190
• Device Lot Number: 739760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 02/05/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 04/03/2024
• 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