MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; DIMENSION® EXL¿ W/ LM VANC VANCOMYCIN FLEX® REAGENT CARTRIDGE

Model Number	10444929
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens healthcare diagnostics customer care center (ccc) and reported that discordant, falsely elevated and falsely depressed vancomycin (vanc) results were obtained on a dimension exl with lm instrument.Siemens is investigating the event.
Event or Problem Description
Discordant, falsely elevated and falsely depressed vancomycin (vanc) results were obtained on a patient sample on a dimension exl with lm instrument.The discordant results were reported to the physician(s) and were questioned.The same sample was reprocessed the same day with an alternate unknown instrument and lower results were obtained, considered correct and reported.A corrected report was issued.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated vanc results.
Additional Manufacturer Narrative
On (b)(6) 2020.Additional information ((b)(6) 2020): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant falsely elevated and falsely depressed vancomycin (vanc) results.Hsc evaluated the information provided and the instrument data files.No issues were noted with other patient samples indicating that the instrument and assays were performing acceptably.The customer has reported no further discordant patient results while continuing to use the same assay lot.The customer and instrument are operational.A potential product issue has not been identified.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION® EXL¿ W/ LM VANC VANCOMYCIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark, de
• MDR Report Key: 10423011
• Report Number: 2517506-2020-00256
• Device Sequence Number: 14197112
• Product Code: LEH
• UDI-Device Identifier: 00842768005763
• UDI-Public: 00842768005763
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K963267
• 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): 09/18/2020

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: 02/12/2021
• Device Model Number: 10444929
• Device Catalogue Number: DF86 SMN 10444929
• Device Lot Number: BC1043
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1