MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FERRITIN; FERRITIN ASSAY

Catalog Number 03737551160

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 08/30/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas e411 rack is (b)(6).The customer stated that the pinch valve tubes were in very bad condition and had not been replaced for more than six months.The customer replaced the pinch valve tubes after a repeat result was obtained.The investigation is ongoing.

Event Description

The initial reporter received a questionable result elecsys ferritin (ferritin) from one patient sample tested on the cobas e411 rack.The initial result was not reported outside the laboratory.A rerun was requested by the laboratory results validation department due to an initial result not matching the patient history.The patient's other sample was also run.On (b)(6) 2023: the initial result of the initial sample was 0.638 ng/ml with a data flag.The result of the other sample was 331.8 ng/ml.On (b)(6) 2023: the repeat result of the initial sample was 336.4 ng/ml.The initial result was deemed an incorrect result.

Manufacturer Narrative

The investigation determined the event was caused by the worn pinch valve tubes.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: ELECSYS FERRITIN
• Type of Device: FERRITIN ASSAY
• 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: 17859481
• MDR Text Key: 324780585
• Report Number: 1823260-2023-03158
• Device Sequence Number: 1
• Product Code: JMG
• UDI-Device Identifier: 04015630938940
• UDI-Public: 04015630938940
• Combination Product (y/n): Y
• Reporter Country Code: EG
• PMA/PMN Number: K971833
• 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: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 03737551160
• Device Lot Number: 64725205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1