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

Catalog Number	08057931190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas pro c 503 analytical unit is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received a questionable result for one patient sample tested with iron2 on a cobas pro c 503 analytical unit.The sample resulted in an iron value of (b)(6).The value was questioned by a physician.A second sample was collected from the patient on (b)(6) 2023 and the iron result was (b)(6).The patient's samples were also tested at another clinic using an unknown method and they received the same results, which were high iron results.No specific data was provided.
Additional Manufacturer Narrative
The patient had a previous iron result of 54 ug/dl in (b)(6) 2021.The patient was admitted to the clinic on (b)(6) 2023.The affected patient sample also had a repeat value of 221 ug/dl on (b)(6) 2023.In b5, the following statement, "a second sample was collected from the patient on (b)(6) 2023 and the iron result was 85 ug/dl." is corrected to "a second sample was collected from the patient on (b)(6) 2023 and the iron result was 84.8 ug/dl.The affected patient sample resulted in the following relevant test data: total bilirubin = 0.932 mg/dl direct bilirubin = 0.302 mg/dl ast = 19.7 u/l alt = 15.8 u/l wbc = 2.74 10^3/ul rbc = 3.92 10^6/ul hgb = 12.7 g/dl hct = 37.6 % mcv = 95.9 fl mch = 32.4 pg mchc = 33.8 g/dl rdw-cv = 15.7 % plt = 197 10^3/ul mpv = 9.2 fl neut = 1.30 10^3/ul (47.4 %) lymph = 0.83 10^3/ul (30.3 %) mono = 0.52 10^3/ul (19.0 %) eo = 0.06 10^3/ul (2.2 %) baso = 0.02 10^3/ul (0.7 %) ig = 0.01 10^3/ul (0.4 %) nrbc = 0.00 10^3/ul (0.0 %).The field service engineer adjusted reagent probes, checked the water pressure, and checked the rinse mechanism.The sample, reagent, and water lines were checked.Calibration and controls were within specifications.Calibration data was acceptable.A product issue could be ruled out.Upon review of the alarm trace, no relevant alarms were observed.The investigation did not identify a product issue.A pre-analytic sample handling issue could not be ruled out.There is no evidence suggesting that both iron test results are incorrect.

• 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: 18521919
• Report Number: 1823260-2024-00157
• Device Sequence Number: 20757833
• Product Code: JIY
• UDI-Device Identifier: 07613336121344
• UDI-Public: 07613336121344
• Combination Product (Y/N): Y
• Initial Reporter State: WY
• 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): 02/06/2024

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: 02/29/2024
• 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): Follow-Up
• Initial Date Received by Manufacturer: 12/26/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/06/2024
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 107 KG