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	07/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The calibration and qc data provided was acceptable.The alarm trace showed multiple sample quality alarms.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys ige ii results for 1 patient sample on a cobas 6000 e601 module.The initial ige result was 134.5 iu/ml.The sample was repeated as the initial result was outside of the reference range.The repeat result was 1.02 iu/ml and the second repeat result was 147.5 iu/ml.The second repeat result was deemed correct.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The field service engineer (fse) found that the sample pipette was very close to the wall of the sample tubes and made adjustments.It was found that the customer was not using rack adapters.The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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 46250-0457
• MDR Report Key: 17475403
• Report Number: 1823260-2023-02553
• Device Sequence Number: 7341771
• Product Code: JHR
• UDI-Device Identifier: 04015630922369
• UDI-Public: 04015630922369
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• 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): 09/01/2023

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: 07/31/2024
• Device Catalogue Number: 04827031190
• Device Lot Number: 67239400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 09/01/2023
• 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: 6 MO
• Patient Sex: Unknown