MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA®; DIMENSION VISTA® DIRECT BILIRUBIN FLEX® REAGENT CARTRIDGE

Catalog Number	K2125 SMN 10445152
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely elevated direct bilirubin (dbi) results.Hsc has reviewed the information provided and concludes that it is not a reagent lot or assay issue.Based on the information and data available, this event is isolated to a single well set (5;1) from flex sequence 1404 and not a reagent lot product problem.The customer has not observed falsely elevated dbi results from any other reagent flexes or well sets of this reagent lot number.The data file indicates an improper preparation of the diazotized sulfanilic acid in well 1.The reagent in well 1 is prepared automatically by the instrument.After loading a new reagent flex, patient and quality control dbi results returned to the laboratory expected values.There is no evidence of a product non-conformance.The cause of the event is unknown.No further evaluation is required.
Event or Problem Description
Discordant, falsely elevated direct bilirubin (dbi) results were obtained on pediatric patient samples on a dimension vista 500 system.The discordant results were reported to the physician who questioned the results.New samples were processed on an alternate dimension vista instrument and lower results were obtained.Corrected reports were issued.One patient (sample id (b)(6)) was treated for the elevated dbi result by having additional blood draws, being fed a special formula instead of breastmilk and having a liver ultrasound which gave a normal result.There were no adverse health consequences due to the discordant falsely elevated dbi results or due to the treatment.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® DIRECT BILIRUBIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. box 6101; newark DE 19714 6101
• MDR Report Key: 8845546
• Report Number: 2517506-2019-00306
• Device Sequence Number: 2859875
• Product Code: CIG
• UDI-Device Identifier: 00842768015649
• UDI-Public: 00842768015649
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K061839
• 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): 07/31/2019

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: 03/20/2020
• Device Catalogue Number: K2125 SMN 10445152
• Device Lot Number: 19080BA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2019
• Initial Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 DA