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

Catalog Number	03183696122
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter received questionable iron2 iron gen.2 (iron2) results from two patient samples tested on the cobas integra 400 plus.The initial results were not reported outside of the laboratory.Patient sample 1: the patient sample was sent out to another laboratory that uses an au480 analyzer for a rerun.It was also rerun on an alinity analyzer.The initial result from the analyzer was 0.4 umol/l with a data flag.The first repeat result from the analyzer was 0.6 umol/l with a data flag.The second repeat result from the other laboratory's au480 analyzer was 2.6 umol/l.This result was reported outside of the laboratory.The third repeat result from the alinity was 2.0 umol/l.Patient sample 2: the reporter used a new reagent pack (with the same lot number as the previous pack) for the repeat result.The initial result using the previous reagent was 0.8 umol/l.The repeat result using the new reagent pack was 3.1 umol/l.

• 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: 17596046
• Report Number: 1823260-2023-02731
• Device Sequence Number: 6430589
• Product Code: JIY
• UDI-Device Identifier: 04015630918904
• UDI-Public: 04015630918904
• Combination Product (Y/N): Y
• Initial Reporter Country: BK
• 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
• Report Date (Section B): 08/22/2023

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): Initial
• Initial Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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