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	07/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas 6000 e601 module is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys ige ii on a cobas 6000 e601 module.No questionable results were reported outside of the laboratory.The sample initially resulted in an ige value of 0.195 ui/ml accompanied by a data flag indicating carryover.There were only 3 tests remaining in the reagent pack during this measurement.The sample was repeated, resulting in an ige value of 958.2 ui/ml.This measurement was performed using a new reagent pack.An additional ige value of < 0.100 ui/ml with a data flag was provided.It was asked, but it is not known if this is an additional repeat value from the complained sample or if it is a result of a different sample.
Additional Manufacturer Narrative
The calibration signals were within expectations.Quality controls performed on 29-jun-2023 and on 03-jul-2023 were within range.The customer did not run controls on the day of the event based on the provided information.Upon review of the alarm trace, no relevant alarms were observed.The investigation could not identify a product problem.The 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17362987
• Report Number: 1823260-2023-02366
• Device Sequence Number: 6079753
• Product Code: JHR
• UDI-Device Identifier: 04015630922369
• UDI-Public: 04015630922369
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 09/01/2023
• 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: 9 YR
• Patient Sex: Unknown