MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY MICROALBUMIN REAGENT

Model Number	ADVIA CHEMISTRY MICROALBUMIN REAGENT
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Falsely depressed microalbumin_2 (alb_2) results were obtained on 2 patient samples on an atellica ch 930 analyzer, serial number (s/n): (b)(4), using advia chemistry microalbumin reagent.The discordant results were reported to the physician(s).The samples were repeated on the same analyzer the following day.The repeat results were higher than the discordant results.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed alb_2 results.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted a siemens customer care center (ccc).The customer was running open channel advia chemistry microalbumin reagent on the atellica ch 930 system due to global reagent shortage.The customer loaded both the atellica ch microalbumin_2 reagent and the advia chemistry microalbumin reagent on the system using the same lot number as the current advia chemistry microalbumin reagent.Quality controls (qc) on the atellica reagent flagged out of range, while qc run on advia reagent recovered in range.A lot calibration was then performed on the atellica reagent, after which qc recovered in range.However, the customer then accidentally ran samples with the advia reagent against the calibration id that was performed on the atellica reagent since both reagents had the same lot number, and the system was unable to differentiate between the two assays.After the customer performed a new calibration using the advia reagent the following day, the patient results were repeated and recovered in acceptably.The cause of the event is use error.The reagent is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CHEMISTRY MICROALBUMIN REAGENT
• Common Device Name: ADVIA CHEMISTRY MICROALBUMIN REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): RANDOX LABORATORIES LTD.; registration # 8020890; 55 diamond road; crumlin co. antrim, BT29 4QY; UK BT29 4QY
• Manufacturer Contact: christopher aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 16158731
• Report Number: 2432235-2023-00010
• Device Sequence Number: 20326468
• Product Code: JIR
• UDI-Device Identifier: 00630414517643
• UDI-Public: 00630414517643
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/13/2023

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: 09/01/2024
• Device Model Number: ADVIA CHEMISTRY MICROALBUMIN REAGENT
• Device Catalogue Number: 10318197
• Device Lot Number: 616644
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown