MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IRON GEN.2; PHOTOMETRIC METHOD, IRON (NON-HEME)

Catalog Number	05169291190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for iron2 on a cobas 8000 c 702 module.The initial result was 951 ug/dl.The repeat result was 58 ug/dl.
Additional Manufacturer Narrative
The c702 module serial number was (b)(6).Calibration was acceptable.Qc data was unstable but was acceptable on the day of the event.Frequent "abnormal aspiration" alarms and many sample pipetting issues were observed on the alarm trace data.The investigation is ongoing.
Additional Manufacturer Narrative
The customer used a sample volume of 3 ml; the target volume was 8 ml.The customer used a clotting time of +/- 120 minutes.The customer used a centrifugation time of 5 minutes at 3728 revolutions per minute (rpm).This time may be too short.Based on the information provided, a general reagent issue can be excluded as calibration and qc were acceptable.The investigation determined the event was consistent with a preanalytical handling issue.

• Brand Name: IRON GEN.2
• 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: 21054420
• Report Number: 1823260-2025-00002
• Device Sequence Number: 8758634
• Product Code: JIY
• UDI-Device Identifier: 04015630925049
• UDI-Public: 04015630925049
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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): 01/17/2025

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: 03/31/2025
• Device Catalogue Number: 05169291190
• Device Lot Number: 78879801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/17/2025
• 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 Age: 32 YR
• Patient Sex: Female