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

Model Number RUBELLA IGG

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).The customer's calibration and qc data were ok.The investigation is ongoing.(b)(6).

Event Description

The initial reporter received questionable elecsys rubella igg immunoassay results for one patient tested with a cobas 8000 e 602 module serial number (b)(4).The initial elecsys rubella igg result was reported outside the laboratory.The customer sent the patient¿s sample to different laboratories for testing on an abbott architect and a biomerieux vidas analyzer.

Manufacturer Narrative

The patient samples from (b)(6) 2020 were no longer available for investigation.A new sample was drawn on (b)(6) 2020 and 2 tubes from this draw were submitted for investigation.Both tubes were run on a cobas e602 with the elecsys rubella igg assay, lot 443879.The results from both tubes were positive: sample1 20.88 kiu/l, sample2 20.72 kiu/l.The customer's results were reproduced at the investigation site.Bothe tubes were run on assays from other manufacturers (platelia rubella igg assay, mikrogen recomblot rubella igg, and neutralization).The platelia rubella igg results were negative, the mikrogen assay results were positive and neutralization was successful.Based on the results from the investigation both tubes are considered to be correctly positive.The elecsys rubella igg assay performs within specifications.A product problem was not found.

• 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: 10476369
• MDR Text Key: 205133631
• Report Number: 1823260-2020-02150
• 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: 11/24/2020

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: 10/31/2020
• Device Model Number: RUBELLA IGG
• Device Catalogue Number: 04618793190
• Device Lot Number: 443879
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR