MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FERRITIN; FERRITIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number 04491785160

Device Problem Unable to Obtain Readings (1516)

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

Event Date 05/26/2023

Event Type  malfunction  

Manufacturer Narrative

Last calibration was performed on (b)(6) and it was accepable with no alarms.The alarm trace contained an abnormal sample probe movement alarm on date of the event.The cobas e601 analyzer was with a serial number of (b)(6).Investigation is ongoing.

Event Description

We received an allegation about discrepant results for 1 patient's serum sample tested with elecsys ferritin (ferr) assay on a cobas 6000 cobas e601 immunoassay analyzer.Initial result: 0.768 ng/ml repeat result: 18.65 ng/ml the questionable result was reported outside the laboratory.The customer noticed the questionable result while reviewing the testing and therefore, repeated the sample.The repeat result was deemed to be correct.

Manufacturer Narrative

There was an alarm indicating an abnormal sample probe movement.Based on the data provided a clear root cause could not be identified.A general instrument or reagent problem could not be identified.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FERRITIN
• Type of Device: FERRITIN IMMUNOLOGICAL TEST SYSTEM
• 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: 17183791
• MDR Text Key: 318032551
• Report Number: 1823260-2023-02046
• Device Sequence Number: 1
• Product Code: JMG
• UDI-Device Identifier: 04015630938957
• UDI-Public: 04015630938957
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04491785160
• Device Lot Number: 69522603
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/21/2023
• 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: 14 YR
• Patient Sex: Female