MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IRON GEN.2; 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	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c501 analyzer serial number is (b)(6).The 701 analyzer serial number was not provided.The customer stated that the patient received an iron isomaltoside injection on (b)(6) 2024.Per product labeling, "in patients treated with iron supplements or metal-binding drugs, the drug-bound iron may not properly react in the test, resulting in artificially low values." the investigation is ongoing.
Event or Problem Description
There was an allegation of questionable iron2 iron gen.2 results for 1 patient on a cobas 6000 c501 module.On (b)(6) 2024, the initial iron result was 22.67 umol/l.The sample was repeated on a maccura analyzer and the iron result was 95.4 umol/l.The sample was also repeated on a fujifilm analyzer and the iron result was 151.7 umol/l.On (b)(6) 2024, the initial iron result was 62.93 umol/l.The sample was repeated on a roche 701 analyzer and the iron result was 73.54 umol/l.The sample was then repeated on a maccura analyzer and the iron result was 231.5 umol/l.The sample was also repeated on a fujifilm analyzer and the iron result was 141.82 umol/l.On (b)(6) 2024, the initial iron result was 36.94 umol/l.The sample was repeated on a maccura analyzer and the result was 100 umol/l.
Additional Manufacturer Narrative
The root cause of the event was found to be consistent with a known interferent in the patient sample covered in product labeling.The investigation did not identify a product problem.

• 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: 19794425
• Report Number: 1823260-2024-02111
• Device Sequence Number: 17916483
• Product Code: JIY
• UDI-Device Identifier: 04015630918904
• UDI-Public: 04015630918904
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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): 09/23/2024

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 Catalogue Number: 03183696122
• Device Lot Number: 752909
• 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: 06/28/2024
• Supplement Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IRON ISOMALTOSIDE MONOFER 500MG/5ML
• Patient Sex: Unknown