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

Catalog Number 04784618190

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the e601 analyzer is (b)(6).The patient sample was provided for investigation.The investigation is ongoing.H3 other text : na.

Event Description

The initial reporter stated they received a questionable result for one patient sample tested with the elecsys cmv igm immunoassay on a cobas 6000 e601 module.No questionable results were reported outside of the laboratory.The sample initially resulted in a cmv igm value of 0.161 coi (non-reactive) when tested with the roche assay.The patient has previously had positive cmv igg, igm, and avidity results.The sample was then sent to another laboratory where it was tested using the biorad multiplex luminex assay, resulting in a cmv igm value of 2.1 coi (positive).

Manufacturer Narrative

The customer's results could be confirmed.The sample was determined to be non-reactive in the elecsys cmv igm assay.Additional analyses showed that the samples contained cmv-specific igg antibodies of high avidity, suggesting that other methods might detect persisting or recurring cmv igm antibodies in the sample.The obtained results are not indicative of an early phase of infection with cmv.The investigation determined the elecsys cmv igm assay performed as intended.The observed reactivity pattern was consistent with the possible detection of persistent igm in competitor assays.

• 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
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17258165
• MDR Text Key: 318921755
• Report Number: 1823260-2023-02175
• Device Sequence Number: 1
• Product Code: LFZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K142133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 04784618190
• Device Lot Number: 663897
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1