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

Catalog Number	CMV IGM ELECSYS E2G
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2022-03250
• Device Sequence Number: 7974994
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K163569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female