MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; DIMENSION® EXL¿ 200 ALBUMIN FLEX® REAGENT CARTRIDGE

Catalog Number	10444975
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted siemens customer care center (ccc) and reported discordant, falsely depressed albumin (alb) patient results were obtained on a dimension exl 200 system.Siemens is investigating the event.
Event or Problem Description
Discordant, falsely depressed albumin (alb) results were obtained on a patient sample on a dimension exl 200 instrument.The discordant results were reported to the physician(s) and were questioned.A new sample was processed using the same instrument and an alternate dimension exl 200 instrument and lower results were obtained.The new sample was also processed on an alternate non-siemens instrument on the same day and higher results were obtained.A corrected report was issued with the higher results.The patient was administered an albumin infusion.There were no adverse health consequences due to the discordant, falsely depressed albumin results or due to treatment.
Additional Manufacturer Narrative
Mdr 2517506-2019-00327 was filed on (b)(4) 2019.Additional information (b)(4) 2019): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely depressed albumin (alb) patient results.The dimension exl uses a bromocresol purple (bcp) assay.Per the instructions for use (ifu) for the albumin method, "because of an enhanced specificity of bcp for albumin, this method is not subject to globulin interference." no product or system non-conformance was identified by this investigation.The cause of this 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¿ 200 ALBUMIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 8911400
• Report Number: 2517506-2019-00327
• Device Sequence Number: 1903743
• Product Code: CJW
• UDI-Device Identifier: 00842768005343
• UDI-Public: 00842768005343
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K861700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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: 02/28/2020
• Device Catalogue Number: 10444975
• Device Lot Number: BA0059
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR