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

Catalog Number 07027117190

Device Problem High Test Results (2457)

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

Event Date 10/15/2021

Event Type  malfunction  

Event Description

The initial reporter received a questionable elecsys cmv igg result for one patient sample with cobas e 801 module (b)(4).The initial result was 1.20 u/ml (reactive).This result was reported outside of the laboratory and questioned by the doctor.On (b)(6) 2021, the sample was tested in another laboratory on an unknown analyzer with a result of negative (non-reactive).

Manufacturer Narrative

The sample was requested for investigation.

Manufacturer Narrative

The customer's calibration and qc results were within specification.The customer's sample pre-analytic details were requested but not provided.The result of the customer could be confirmed.Further investigation suggests that the sample is consistent with a false positive in the elecsys cmv igg assay.Based on data presented in product labeling, single false positives can occur.The reagent performs within specification.A general product problem was not found.

• Brand Name: ELECSYS CMV IGG ASSAY
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12793606
• MDR Text Key: 285002910
• Report Number: 1823260-2021-03328
• Device Sequence Number: 1
• Product Code: LFZ
• UDI-Device Identifier: 04015630940172
• UDI-Public: 04015630940172
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K131605
• 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: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 07027117190
• Device Lot Number: 568054
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• 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 Sex: Female