MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IRON2; PHOTOMETRIC METHOD, IRON (NON-HEME)

Catalog Number	03183696122
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One of the integra 400 plus modules' serial number is (b)(6).The other module's serial number was not provided.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable iron2 iron gen.2 results for 2 patient samples on two cobas integra 400 plus modules.For sample 1, the initial iron result was 3.65 ug/dl.The sample was repeated on another integra 400 plus module and the result was 14.48 ug/dl.For sample 2, the initial iron result was 13.46 ug/dl.The sample was repeated on another integra 400 plus module and the result was 25.30 ug/dl.Clarification on which analyzer produced which results was not provided.
Additional Manufacturer Narrative
The calibration and qc recovery data provided was acceptable.The alarm trace showed multiple no fluid detected alarms.The field service engineer (fse) found a problem with the analyzer lamp and replaced it.The root cause of the event was found to be consistent with customer maintenance issues.

• Brand Name: IRON2
• Common Device Name: PHOTOMETRIC METHOD, IRON (NON-HEME)
• 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: 17775455
• Report Number: 1823260-2023-03023
• Device Sequence Number: 18014976
• Product Code: JIY
• UDI-Device Identifier: 04015630918904
• UDI-Public: 04015630918904
• Combination Product (Y/N): Y
• Initial Reporter Country: RO
• PMA/510(K) Number: K951595
• 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): 12/07/2023

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: 02/29/2024
• Device Catalogue Number: 03183696122
• Device Lot Number: 71147001
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 12/07/2023
• 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 Sex: Unknown