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 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

Sample from the patient was requested for investigation.The investigation is ongoing.

Event Description

There was an allegation of questionable rubella igm elecsys results from cobas 8000-cobas e 602 module serial number (b)(4).Three samples from the patient were used for the testing.It was requested but was unclear which samples were used for which testing.On (b)(6) 2021, the result at another laboratory using diasorin liaison xl was 65.8 au/ml (reactive).On (b)(6) 2021, the result at another laboratory using diasorin liaison xl was reactive.On (b)(6) 2021, the result was 0.414 coi (non-reactive).From a new sample on (b)(6) 2021, the result was 0.455 coi (non-reactive).On (b)(6) 2021, the result from another laboratory using a cobas e801 analyzer was reactive.It was not clear if the same sample was tested.The questionable results were not reported outside of the laboratory.

Manufacturer Narrative

Sample from the patient was received for investigation and the elecsys rubella igm results were reproducible as non-reactive on both a cobas e801 analyzer and a cobas e601 analyzer.The platelia rubella igm results were both positive.The euroimmun avidity assay results were both indeterminate avidity.The investigation determined a recent infection is unlikely and the negative result of the elecsys assay is considered correct.The reagent performed within specification.

• 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
• MDR Report Key: 12160307
• MDR Text Key: 267868420
• Report Number: 1823260-2021-02007
• Device Sequence Number: 1
• Product Code: LFX
• Combination Product (y/n): N
• PMA/PMN Number: K092322
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 04618831190
• Device Lot Number: 51360800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 28 YR