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

Catalog Number 04827031190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 09/12/2023

Event Type  malfunction  

Event Description

The initial reporter received a questionable elecsys ige ii result from one patient sample tested on the cobas e411 disk.The initial result was 405.1 ng/ml.The repeat result was 253.2 ng/ml.

Manufacturer Narrative

The serial number of the customer's cobas e411 disk is (b)(6).The field service engineer performed preventive maintenance on the analyzer.The investigation is ongoing.

Manufacturer Narrative

The field service engineer replaced the pinch valves.On his second service visit, he performed mechanical and instrument checks.The investigation noted that the customer does not use rack adapters for the 13 mm sample tubes.Product labeling states "inserting a roche rack cup adapter into a rack - use roche rack cup adapters to improve the alignment of 13 mm tubes.Warning ! incorrect results and errors due to misaligned sample tubes not using a roche rack cup adapter with 13 mm tubes or incorrect use of a roche rack cup adapter may cause incorrect results or errors.Always use roche rack cup adapters with 13 mm tubes.Ensure that sample tubes are straight." the investigation reviewed the calibration data and noted that the calibration signals may be lower than expected.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.The cause of the event could not be determined.

• Brand Name: ELECSYS IGE II
• Type of Device: 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: 17887100
• MDR Text Key: 325120811
• Report Number: 1823260-2023-03218
• Device Sequence Number: 1
• Product Code: JHR
• UDI-Device Identifier: 04015630922369
• UDI-Public: 04015630922369
• Combination Product (y/n): Y
• Reporter Country Code: AR
• PMA/PMN Number: K061970
• 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: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04827031190
• Device Lot Number: 619033
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• 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 Age: 25 YR
• Patient Sex: Female