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

Catalog Number	03183696122
Medical Device Problem Codes	Low Test Results (2458); Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of qc issues and questionable iron gen.2 results from the cobas integra 400 plus analyzer.One example was an initial result of 7 ug/dl and a repeat result of 53 ug/dl.The questionable results were not reported outside of the laboratory.
Additional Manufacturer Narrative
The customer reported they typically have to calibrate several times before the calibration passes and keep the cfas calibrator material in the refrigerator for 7 days before making a new bottle.The current cfas being used by the customer was reconstituted on (b)(6) 2023.Per product labeling, the stated stability of the cfas calibrator material is only 2 days at 2-8c.The customer installed a new pack of the reagent, reconstituted fresh cfas material, and calibrated the new reagent pack.The customer confirmed the issue was resolved.The investigation determined the issue was due to a use error and was resolved by customer education regarding product handling.

• 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: 17776812
• Report Number: 1823260-2023-03025
• Device Sequence Number: 15298587
• Product Code: JIY
• UDI-Device Identifier: 04015630918904
• UDI-Public: 04015630918904
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 11/21/2023

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: 06/30/2023
• Device Catalogue Number: 03183696122
• Device Lot Number: 64195701
• 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: 08/28/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 11/21/2023
• 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: 83 YR
• Patient Sex: Female