MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS RUBELLA IGM IMMUNOASSAY; RUBELLA VIRUS SEROLOGICAL REAGENT

Catalog Number 04618831190

Device Problem False Negative Result (1225)

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

Event Date 05/07/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique device identifier (udi) (b)(4).The customer's calibration results were low but acceptable.The customer's qc prior to the date of the event were within range and out of range.No qc was provided on the date of the event.The investigation determined the customer's actions of replacing the reagent pack resolved the issue.

Event Description

The initial reporter received questionable elecsys rubella igm immunoassay results for one patient tested on a cobas e 411 immunoassay analyzer serial number (b)(4).The initial elecsys rubella igm result was not reported outside the laboratory.The customer sent the patient's sample to another laboratory for testing with "chemileuminses" methodology.On (b)(6) 2021, the patient's elecsys rubella igm result was 0.594 coi non-reactive.On (b)(6) 2021, the patient's rubella igm result at the other laboratory was reactive.No numeric result was provided.On an unknown date, the customer replaced the elecsys rubella igm reagent pack.The customer performed qc and had acceptable results.The customer tested the patient's sample with the new rubella igm reagent, and the patient's rubella igm result was reactive.No numeric result was provided.

• Brand Name: ELECSYS RUBELLA IGM IMMUNOASSAY
• Type of Device: RUBELLA VIRUS SEROLOGICAL REAGENT
• 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: 12050123
• MDR Text Key: 271530482
• Report Number: 1823260-2021-01801
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K092322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 04618831190
• Device Lot Number: 500006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2021
• 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