MAUDE Adverse Event Report: ROCHE DIAGNOSTICS RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS; ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Catalog Number 04618793190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)# (b)(4).The event occurred in: (b)(6).

Event Description

The customer complained of questionable elecsys rubella igg immunoassay (rubella igg) results for 2 patient samples tested on a cobas 8000 e 602 module.For patient 1 the initial rubella igg result was 8 ui/ml, non reactive.The rubella igg result from another lot of reagent was 16 ui/ml, reactive.For patient 2 the initial rubella igg result was 8 ui/ml, non reactive.The rubella igg result from another lot of reagent was 16 ui/ml, reactive.The lot information for the other lot of rubella igg reagent was requested but was not provided.It was unknown if the erroneous results were reported outside of the laboratory.There was no allegation of an adverse event.The cobas e602 serial number was (b)(4).The investigation is currently ongoing.

Manufacturer Narrative

The customer provided patient data that was more specific.For patient 1 the initial rubella igg result was 8.91 ui/ml, non reactive.The rubella igg result from another lot of reagent was 15.38 ui/ml, reactive.For patient 2 the initial rubella igg result was 7.92 ui/ml, non reactive.Patient 2 date of birth is (b)(6) who is (b)(6) years old.

Manufacturer Narrative

A sample from both patients 1 and 2 was provided for further investigation.The results observed by the customer were not reproduced.Using two different lots of rubella igg, lots 267421 and 283664, the rubella igg results for both patients were negative.The investigation was unable to find a definitive root cause.

Manufacturer Narrative

The calibration and qc results were acceptable.

• Brand Name: RUBELLA IGG - IGG ANTIBODIES TO RUBELLA VIRUS
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7570407
• MDR Text Key: 110125335
• Report Number: 1823260-2018-01751
• 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,Followup
• Report Date: 08/23/2018

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: 04618793190
• Device Lot Number: 283664
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 05/18/2018; 05/18/2018; 05/18/2018
• Supplement Dates FDA Received: 06/21/2018; 07/31/2018; 08/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR