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

Catalog Number	03183696122
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for five patient samples tested with iron gen.2 on a cobas integra 400 plus.The first sample resulted in an iron value of 0.5 umol/l when tested on the integra 400 plus.The sample resulted in an iron value of 2.2 umol/l when tested at another site on an unknown instrument.The second sample resulted in an iron value of 1.9 umol/l when tested on the integra 400 plus.The sample resulted in an iron value of 3.9 umol/l when tested at another site on an unknown instrument.The third sample resulted in an iron value of 2.1 umol/l when tested on the integra 400 plus.The sample resulted in an iron value of 7.0 umol/l when tested at another site on an unknown instrument on (b)(6) 2024.The fourth sample resulted in an iron value of 1.5 umol/l when tested on the integra 400 plus.The sample resulted in an iron value of 7.7 umol/l when tested at another site on an unknown instrument on (b)(6) 2024.The fifth sample initially resulted with an iron value of 1.6 umol/l when tested on the integra 400 plus on (b)(6) 2024.The customer repeated calibration and controls; these were acceptable.The primary tube of the sample was then repeated on the same analyzer, resulting in an iron value of 6.6 umol/l.
Additional Manufacturer Narrative
The serial number of the cobas integra 400 plus analyzer is (b)(6).Quality controls were acceptable on (b)(6) 2024.A review of qc data from (b)(6) 2024 showed that results for the first level of control were unstable, with some values outside of range.The investigation is ongoing.
Additional Manufacturer Narrative
Quality controls were acceptable on the day of the event.The field service engineer decontaminated the instrument and cleaned the rinse stations and probes.Splash protection was carried out.The customer stated that the iron measurements have improved.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 19763726
• Report Number: 1823260-2024-02061
• Device Sequence Number: 8725042
• 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,Followup
• Report Date (Section B): 10/07/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 10/07/2024
• 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
• Patient Sex: Unknown