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

Catalog Number 07027770190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/12/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer received questionable elecsys rubella igg immunoassay results for one patient from cobas e 801 module serial number (b)(4).The rubella igm result was 7.67 (positive) and the rubella igg result was 8.15 u/ml (negative).The customer suspected acute infection.The sample was repeated and the same results were received.The rubella pcr from a throat swab was negative.The customer sent an aliquot of the same sample to the reference laboratory.The igg result was 31 u/ml (positive) and the igm result was negative which indicated an immunized patient.The results were reported outside of the laboratory.There was no allegation of an adverse event.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

Customer¿s negative result of rubella igg and positive result of rubelia igm measured with cobas e 801 could be confirmed.

• 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: 8111501
• MDR Text Key: 129195797
• Report Number: 1823260-2018-04520
• 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,Followup
• Report Date: 02/11/2019

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: 07027770190
• Device Lot Number: 31103600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 11/28/2018
• Supplement Dates Manufacturer Received: 11/08/2018; 11/08/2018
• Supplement Dates FDA Received: 01/25/2019; 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR