MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® TOTAL BILIRUBIN FLEX® TBI REAGENT CARTRIDGE

Catalog Number	DF 167 SMN 10444957
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	09/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely depressed and falsely elevated total bilirubin (tbi) results.Hsc analysis of the instrument photometer data indicates the patient samples identified as the "neat" undiluted sample by the customer were actually the diluted sample.Conversely, patient samples identified by the customer as the diluted sample were actually the "neat" undiluted sample.Hsc concludes the cause of the discordant tbi results was due to the use error of switching the order of the "neat" undiluted sample with the diluted sample in the segment locations on the instrument.Hsc has reviewed the information provided and concludes that it this event was not a reagent lot issue or an assay issue.There is no evidence of a product nonconformance.The device is performing within specifications.No further evaluation of the device is required.
Event or Problem Description
Discordant, falsely depressed and discordant falsely elevated total bilirubin (tbi) results were obtained on a patient sample on the dimension exl system.The discordant results were not reported to the physician.The same samples were reprocessed the same day and a correct result was obtained.The correct result was reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed and falsely elevated tbi results.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® TOTAL BILIRUBIN FLEX® TBI REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7975101
• Report Number: 2517506-2018-00571
• Device Sequence Number: 11066375
• Product Code: CIG
• UDI-Device Identifier: 00842768020544
• UDI-Public: 00842768020544
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K060628
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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: 07/26/2019
• Device Catalogue Number: DF 167 SMN 10444957
• Device Lot Number: FB9207
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1