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

Catalog Number	07027133190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 801 module serial number was (b)(6).As sufficient sample material remained, further investigation was not possible.The investigation was not able to determine a specific root cause.No product problem was found.
Event or Problem Description
There was an allegation of questionable elecsys cmv igm and elecsys cmv igg results from one patient from the cobas e 801 module.This medwatch is for the elecsys cmv igm assay.Refer to the medwatch with a1 patient identifier (b)(6) for the elecsys cmv igg assay.Sample 1 (b)(6) 2025) at 10 weeks of pregnancy: the elecsys cmv igm result was 0.38 coi with a data flag (negative).The elecsys cmv igg result was 0.150 u/ml with a data flag (negative).On (b)(6) 2025, the diasorin liaison cmv igm result was 23.1 ua/ml (positive).The diasorin liaison cmv igg result was 48 ua/ml (positive).The diasorin liaison cmv igg avidity result was 0.0493.The vidas biomérieux cmv igg result was <6 ua/ml (greyzone/equivocal).On (b)(6) 2025, the repeat elecsys cmv igm result using reagent lot 848029 was 0.40 coi (negative).Elecsys cmv igg result using reagent lot 836250 was 0.150 u/ml with a data flag (negative).Sample 2 (b)(6) 2025) 19 weeks of pregnancy: the elecsys cmv igm result was 2.72 coi.The repeat result was 2.67 coi (positive).The elecsys cmv igg result was 10.8 u/ml.The repeat result was 10.6 u/ml (positive).On (b)(6) 2025, the diasorin liaison cmv igm result was 25.4 ua/ml (positive).The diasorin liaison cmv igg result was 155 ua/ml (positive).The diasorin liaison cmv igg avidity result was 0.0797.The vidas biomérieux cmv igg result was 43 ua/ml (positive).The vidas biomérieux cmv igg avidity result was 59 %.Sample 3 (b)(6) 2025) 27 weeks of pregnancy: on (b)(6) 2025, the diasorin liaison cmv igm result was 30.1 ua/ml (positive).The diasorin liaison cmv igg result was 180 ua/ml (positive).The diasorin liaison cmv igg avidity result was 0.156.The vidas biomérieux cmv igg result was 108 ua/ml (positive).The vidas biomérieux cmv igg avidity result was 74 %.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23696220
• Report Number: 1823260-2025-04911
• Device Sequence Number: 10375383
• Product Code: LFZ
• UDI-Device Identifier: 04015630940189
• UDI-Public: 04015630940189
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2025

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: 10/31/2025
• Device Catalogue Number: 07027133190
• Device Lot Number: 825551
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 32 YR
• Patient Sex: Female