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

Model Number	C503
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for iron gen.2 (iron2) on a cobas pro c 503 analytical unit.The initial result was 27.5 ug/dl with a data flag.The repeat result was 64.9 ug/dl with a data flag.The sample was repeated twice on a different c503 analyzer with results of 26.0 ug/dl with a data flag and 26.8 ug/dl with a data flag.The sample was repeated twice on the c503 analyzer in question with results of 28.7 ug/dl with a data flag and 27.4 ug/dl with a data flag.The initial result of 27.5 ug/dl was believed to be correct.
Additional Manufacturer Narrative
The iron2 reagent lot number was 71146501 with an expiration date of 29-feb-2024.The field service engineer (fse) visually inspected the sample with no abnormalities.Precision testing was performed with the sample as well as a serum qc pool.All results correlated with the original result of 27.5 ug/dl.A cause for the event was not identified.Instrument performance was verified and the issue appears to be resolved at the customer site.The investigation did not identify a product problem.The cause of the event could not be determined.
Additional Manufacturer Narrative
Section d, device identification was updated.Relevant fields of sections d and g were updated.The c503 analyzer serial number was (b)(6).Calibration was last performed on 01-jul-2023 with acceptable results.Qc was acceptable.There is no indication of a reagent or instrument performance issue.The customer used a centrifugation speed of 2160 revolutions per minute (rpm) for 5.5 minutes.This centrifugation time may be too short and the speed may be too slow based on the sample tubes the customer uses.

• 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): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17389633
• Report Number: 1823260-2023-02472
• Device Sequence Number: 6351716
• Product Code: JIY
• UDI-Device Identifier: 07613336121344
• UDI-Public: 07613336121344
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023
• 2 Devices were Involved in the Event: 1 2

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 Model Number: C503
• Device Catalogue Number: 08057931190
• Device Lot Number: 71146501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 09/07/2023
• 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