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

Model Number RUBELLA IGG

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.This event occurred in (b)(6).

Event Description

The initial reporter received questionable elecsys rubella igg immunoassay results for one patient from cobas 8000 cobas e 602 module serial number (b)(4).Sample 1 result was 1.47 (non-reactive).On (b)(6) 2019, sample 2 results were 30.37 (reactive) and 30.36 (reactive).Sample 1 was then retested and the result was 1.54 (non-reactive).Both samples were tested in another laboratory by an unknown method: sample 1 result was 11 (reactive).Sample 2 result was 10 (reactive).It was unknown if any questionable result was reported outside of the laboratory.

Manufacturer Narrative

Sample from the patient could not be provided for investigation.Therefore, the cause of the event could not be determined.The investigation did not identify a product problem.

• Brand Name: ELECSYS RUBELLA IGG IMMUNOASSAY
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9361721
• MDR Text Key: 219129144
• Report Number: 1823260-2019-04170
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• PMA/PMN Number: K072617
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

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: 03/31/2020
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 04618793190
• Device Lot Number: 403577
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 11/05/2019
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR