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 Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer complained of false negative results for 1 patient tested for elecsys rubella igg immunoassay (rubella igg) on a cobas 6000 e 601 module.On (b)(6) 2018 the patient was tested for rubella igg on the e601 module and the result was 5.46 iu/ml (negative).This result was reported outside of the laboratory.On (b)(6) 2018 the patient went to another laboratory where a new sample was obtained.The rubella igg result from the immulite technic method as 21 iu/ml (positive) and the result from the diasorin method was 33 iu/ml (positive).On (b)(6) 2018 a new sample was obtained and the rubella igg result from the e601 module was 5.26 iu/ml (negative).This sample was sent to an external laboratory where the result from the diasorin method was 38 iu/ml (positive) and the result from the abbott alinity method was 4 iu/ml (negative).The customer is not sure which results are correct.There was no allegation that an adverse event occurred.The e601 module serial number was (b)(4).The sample from (b)(6) 2018 was submitted for investigation.The rubella igg result at the investigation site was 5.32 iu/ml(negative) which reproduced the customer's result.The rubella igg result seems to be plausible as the rubella igm result at the investigation site was also negative (0.299).A reagent issue was not identified.The investigation is ongoing.

Manufacturer Narrative

The sample was investigated further using the platelia rubella igg assay and mikrogen recomblot.The sample tested as weak positive with the platelia rubella igg assay (15.1 iu/ml) and positive with the recomblot method.The patient sample was determined to be positive for rubella igg.A product problem was not found.The assay performed within specification.

• 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: 7507667
• MDR Text Key: 108374512
• Report Number: 1823260-2018-01450
• 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: 07/23/2018

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: 28366401
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 04/23/2018
• Supplement Dates FDA Received: 07/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 33 YR