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

Catalog Number CMV IGM ELECSYS E2G

Device Problem False Negative Result (1225)

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

Event Date 09/20/2022

Event Type  malfunction  

Event Description

There was an allegation of questionable false negative cmv igm elecsys results from cobas e 801 analytical unit serial number (b)(4).For a sample collected on (b)(6) 2022, the result was negative.When tested on a vidas analyzer, the result was positive.For a sample collected on (b)(6) 2022, the result was negative.When tested on a vidas analyzer, the result was positive.The questionable results were reported outside of the laboratory.

Manufacturer Narrative

The samples in question were submitted for investigation.For the (b)(6) 2022 sample: the cmv igm result was 0.466 coi (non-reactive).The cmv igg result after dilution was 1724 u/ml (reactive).The cmv igg avidity was 60.9%.For the (b)(6) 2022 sample: the cmv igm result was 0.377 coi (non-reactive).The cmv igg result after dilution was 1612 u/ml (reactive).The cmv igg avidity was 61.6%.The customer's results were reproducible.A general reagent issue can be excluded.The investigation is ongoing.

Manufacturer Narrative

The calibration and qc data were within the expected ranges.Additional analysis showed the samples contained cmv-specific igg antibodies of high avidity, suggesting that other methods might detect persisting cmv igm antibodies in the samples.The obtained results are not indicative of an early phase of infection with cmv.Medwatch fields a2 - age at time of event, a3 - sex, and b7 - other relevant history were updated.

• Brand Name: ELECSYS CMV IGM
• 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: 15632292
• MDR Text Key: 303143042
• Report Number: 1823260-2022-03250
• Device Sequence Number: 1
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K163569
• 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: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: CMV IGM ELECSYS E2G
• Device Lot Number: 63027501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• 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
• Patient Age: 25 YR
• Patient Sex: Female