MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IRON GEN.2; 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	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable iron gen.2 results for 2 samples taken at the same time from 1 patient on the cobas 6000 c501 module.Sample 1 initial result was 6.63 umol/l.Sample 2 initial result was 8.24 umol/l.On (b)(6) 2024, the samples were repeated.Sample 1 repeat results were 6.26, 5.90, 5.68, and 5.90 umol/l.Sample 2 repeat results were 8.96, 5.74, 5.60, and 5.57 umol/l.On (b)(6) 2024, the samples were repeated sample 1 repeat result was 7.41 umol/l.Sample 2 repeat result was 7.35 umol/l.On 16-jul, the samples were tested on a cobas c702 at another site.Sample 1 results were 5.495 and 5.595 umol/l twice.Sample 2 results were 5.409 and 5.314 umol/l twice.The questionable results were not reported outside of the laboratory.
Additional Manufacturer Narrative
The cobas 6000 c501 module serial number was (b)(6).A general reagent issue was ruled out because calibration and quality control were acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
Due to the limited data provided, the specific cause of the event could not be determined.Based on alarms in the analyzer alarm trace, the event was consistent with a general pre-analytical issue.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: 19927577
• Report Number: 1823260-2024-02287
• Device Sequence Number: 8375618
• 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): 09/17/2024

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 Expiration Date: 02/28/2025
• Device Catalogue Number: 03183696122
• Device Lot Number: 78216601
• 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: 07/16/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/17/2024
• 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: Female