MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA®; DIMENSION VISTA® DIGXN LOCI DIGOXIN FLEX® REAGENT CARTRIDGE

Catalog Number	K6435 SMN10488927
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2017-00861, mdr 2517506-2017-00862, mdr 2517506-2017-00863, mdr 2517506-2017-00864, mdr 2517506-2017-00865, mdr 2517506-2017-00866, mdr 2517506-2017-00867, mdr 2517506-2017-00868, mdr 2517506- 2017-00869, mdr 2517506-2017-00870, mdr 2517506-2017-00871, mdr 2517506-2017-00872, mdr 2517506-2017-00873, mdr 2517506-2017-00874 were also filed for the same customer inquiry.The customer contacted siemens customer care center for the discordant elevated digoxin result on the dimension vista instrument.Quality control was within specification during testing.Siemens is investigating the incident.
Event or Problem Description
A discordant falsely elevated digoxin (digxn) result was obtained on a patient sample on the dimension vista 1500 instrument.The result was reported to the physician who questioned the result.A new sample was tested earlier and repeated on an alternate vista instrument and high results were obtained.A new sample was drawn and tested again on an alternate vista instrument and a high result was obtained.A new sample was drawn and tested at an alternate facility using an alternate methodology and a lower result was obtained.There is no known report of patient adverse health consequences due to the discordant falsely elevated digxn result.
Additional Manufacturer Narrative
Original mdr 2517506-2017-00875 was filed (b)(6) 2017.Mdr 2517506-2017-00861, mdr 2517506-2017-00862, mdr 2517506-2017-00863, mdr 2517506-2017-00864, mdr 2517506-2017-00865, mdr 2517506-2017-00866, mdr 2517506- 2017-00867, mdr 2517506-2017-00868, mdr 2517506- 2017-00869, mdr 2517506-2017-00870, mdr 2517506-2017-00871, mdr 2517506-2017-00872, mdr 2517506-2017-00873, mdr 2517506-2017-00874 were also filed for the same customer inquiry.The cause for the falsely discordant elevated digxn result is unknown based upon the information provided by the customer.Digxn quality control (qc) recovery was within acceptable ranges during the time of this issue.There were no additional complaints on the same digxn lot 17103bc.Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant elevated digoxin (digxn) result obtained on a patient sample on the dimension vista system.Siemens requested the sample to be returned for evaluation but none was provided.Since no sample is available for further investigation of this sample, no further investigation can be performed.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® DIGXN LOCI DIGOXIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7104090
• Report Number: 2517506-2017-00875
• Device Sequence Number: 1574651
• Product Code: KXT
• UDI-Device Identifier: 00842768028335
• UDI-Public: 00842768028335
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K093441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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: 04/13/2018
• Device Catalogue Number: K6435 SMN10488927
• Device Lot Number: 17103BC
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 01/04/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR