MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS IGE II; RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E)

Catalog Number	04827031190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e411 rack serial number was (b)(6).The calibration and qc results were within specifications.Preventive maintenance was performed and the sample/reagent probe and sipper probe adjustments were checked along with the bead mixer function, photomultiplier high voltage, blankcell calibration and performance testing.
Event or Problem Description
There was an allegation of questionable elecsys ige ii results from the cobas e411 rack analyzer.The initial result was 0.931 iu/ml and the repeat result was 589.9 iu/ml with a data flag.
Additional Manufacturer Narrative
Data was provided for an additional patient sample with questionable elecsys ige ii results from the cobas e411 rack analyzer.On (b)(6) 2024, the initial result was 1.04 iu/ml and the repeat result was 14.74 iu/ml.The investigation did not identify a product problem.The cause of the event could not be determined.A general reagent problem was not present, because the qc prior to the event was within ranges.

• Brand Name: ELECSYS IGE II
• Common Device Name: RADIOIMMUNOASSAY, IMMUNOGLOBULINS (D,E)
• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 19321624
• Report Number: 1823260-2024-01454
• Device Sequence Number: 17732115
• Product Code: JHR
• UDI-Device Identifier: 04015630922369
• UDI-Public: 04015630922369
• Combination Product (Y/N): Y
• Initial Reporter Country: IN
• PMA/510(K) Number: K061970
• 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,Followup
• Report Date (Section B): 05/29/2024

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: 07/31/2025
• Device Catalogue Number: 04827031190
• Device Lot Number: 762905
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 05/29/2024
• 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 Sex: Unknown