MAUDE Adverse Event Report: DIMENSION VISTA 1500 INSTRUMENT

Model Number	DIMENSION VISTA 1500
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A flagged falsely elevated beta human chorionic gonadotropin (bhcg) patient sample test result was obtained from a dimension vista 1500 instrument.Siemens reviewed the available information and found the test result was flagged with an "abnormal assay" flag.The dimension vista 1500 operator's guide provides this explanation for the flag: the result monitor feature uses existing loci, nephelometric, and photometric reads to check for reagent quality and delivery and, for some methods, sample delivery.The message indicates that expected absorbance/kcounts were not met for a specific cuvette or loci reaction vessel.The result cannot be reported.Rerun the sample.The cause of reporting a non-reportable flagged test result is an unintentional use error.The instrument is performing with specifications.No further evaluation of this instrument is needed.
Event or Problem Description
A flagged falsely elevated beta human chorionic gonadotropin (bhcg) patient sample test result was obtained from a dimension vista 1500 instrument.The initial test result was reported to the physician(s).The same sample was repeated on an alternate dimension vista 1500 instrument and a lower, unflagged test result was obtained.The repeat result was not reported as the correct result to the physician(s).The laboratory stated the difference in test results was clinically insignificant.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated bhcg result.
Additional Manufacturer Narrative
The initial mdr 2517506-2021-00200 was submitted on 18-aug-2021.Additional information (19-aug-2021): a siemens customer service engineer (cse) was dispatched to the customer site to inspect the instrument.The cse replaced the sample 1 (s1) mixer, the integrated multisensor technology (imt) mixer and the reagent 2 (r2) mixer.The cse performed an auto-alignment and precision aligned the mixers.The cse ran the service methods and system check with acceptable results.

• Brand Name: DIMENSION VISTA 1500 INSTRUMENT
• Common Device Name: DIMENSION VISTA 1500
• MDR Report Key: 12338835
• Report Number: 2517506-2021-00200
• Device Sequence Number: 17278736
• Product Code: JJE
• UDI-Device Identifier: 00630414949536
• UDI-Public: 00630414949536
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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: DIMENSION VISTA 1500
• Device Catalogue Number: 10459469
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1