MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CMV IGM IMMUNOASSAY; ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Catalog Number ASKU

Device Problem False Positive Result (1227)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi) #: (b)(4).The country of origin is (b)(6).The investigation is ongoing.The expiration date was provided as june 2021.

Event Description

The initial reporter complained of questionable elecsys toxo igm results and elecsys cmv igm immunoassay results for 1 patient sample on a cobas 6000 e 601 module analyzer serial number (b)(4).This medwatch will cover the cmv igm reagent.Refer to the medwatch with patient identifier (b)(6) for information related to the toxo igm reagent.The sample was tested with the elecsys cmv igm assay resulting in a value of 1.62 coi (reactive).The sample was repeated on the vidas biomérieux cmv igm assay resulting in a "negative" value.The specific result was not provided.The sample was tested twice with the elecsys toxo igm assay resulting in values of 3.73 coi (reactive) and 3.72 coi (reactive).The sample was repeated on the vidas biomérieux toxo igm assay resulting in a value of <0.55 index (non-reactive).It was unknown if the results were reported outside the laboratory.

Manufacturer Narrative

The sample was provided for investigation where the toxo igm results could be reproduced.The investigation determined the sample contains an interferent to the ruthenium component for both toxo igm and cmv igm.This particular patient sample is not suitable for elecsys toxo igm and cmv igm, due to the ruthenium label used in these assays.Per product labeling, "in rare cases, interference due to extremely high titers of antibodies to immunological components, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the elecsys toxo igm and cmv igm assays performed within specification.

• Brand Name: ELECSYS CMV IGM IMMUNOASSAY
• Type of Device: ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11387855
• MDR Text Key: 268479547
• Report Number: 1823260-2021-00597
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• PMA/PMN Number: K142133
• 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: 03/22/2021

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: ASKU
• Device Lot Number: 484045
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1