MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CHEMISTRY 1800

Model Number	ADVIA CHEMISTRY 1800
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Falsely elevated calcium_2 (ca_2) results were obtained on multiple patient samples on an advia chemistry 1800 instrument.The discordant results were not reported to the physician(s).The patient samples were repeated on an alternate advia chemistry 1800 instrument.The repeat results from an alternate advia chemistry 1800 instrument 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 discordant ca_2 results.This mdr is being filed in an abundance of caution as the customer did not provide patient data for all of the affected samples.
Additional Manufacturer Narrative
A united states customer contacted a siemens customer care center and reported that falsely elevated calcium_2 (ca_2) results were obtained on multiple patient samples on an advia chemistry 1800 instrument.Quality controls (qcs) were acceptable on the day of event.When the customer noticed the elevated ca_2 results, they ran qc, which recovered high and out of range.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse checked water pressure which was acceptable.Then, the cse checked and unclogged the reaction tray wash unit (wud) and dilution tray wash unit (dwud) nozzles and probes.The cse also checked probe alignments, which was acceptable.Then, the cse cleaned water filters and rinsed the water bottle.Lastly, the customer ran qc, which recovered within acceptable ranges.The cause of the discordant ca_2 results is unknown.The instrument is performing according to specifications.No further evaluation of these devices is required.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2022-00269 on 29-sep-2022.Additional information (30-sep-2022): siemens further investigated the incident and concluded that inadequate washing, as a result of clogged reaction tray wash unit (wud) and dilution tray wash unit (dwud) nozzles and probes, potentially contributed to the discordant calcium_2 (ca_2) results.The investigation conclusions code in section h6 was updated based on the additional information.The instrument is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ADVIA CHEMISTRY 1800
• Common Device Name: ADVIA CHEMISTRY 1800
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): JEOL LTD; 3-1-2 musashino akishima; registration #: 3003637681; tokyo, 196-8 558; JA 196-8558
• Manufacturer Contact: christina lam ; 511 benedict avenue; tarrytown, NY 10591 ; 9142550090
• MDR Report Key: 15511183
• Report Number: 2432235-2022-00269
• Device Sequence Number: 20076593
• Product Code: JJE
• UDI-Device Identifier: 00630414534794
• UDI-Public: 00630414534794
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K990346
• 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): 10/06/2022

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 Model Number: ADVIA CHEMISTRY 1800
• Device Catalogue Number: 10315183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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