MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® BETA HUMAN CHORIONIC GONADOTROPIN FLEX® REAGENT CARTRIDGE

Catalog Number	K6430 SMN 10445107
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) about a discordant elevated bhcg patient result obtained on the dimension vista.Siemens is investigating the event.
Event or Problem Description
A discordant elevated human chorionic gonadotropin (bhcg) result was obtained on a patient sample on the dimension vista 500 system.The result was not reported to the physician but was questioned by the customer who stated the elevated result was higher than expected.There are no known reports of patient intervention or adverse health consequences due to the discordant elevated human chorionic gonadotropin (bhcg) result.
Additional Manufacturer Narrative
Original mdr (b)(6) 2018.Additional information (21-may-2018): the customer stated that they also sent the patient sample to be analyzed by an alternate methodology (methodology not provided).They did not provide the exact result obtained but mentioned that the result matched the result of 14,967 miu/ml.Siemens headquarters support center (hsc) has reviewed the instrument data and completed their evaluation.Both initial results were flagged with e521: above assay range which is a non-reportable result as stated in the vista operators guide.Both vista's recovered >200,000 miu/ml on the initial run/auto-dilution of the sample and these were both processed from the primary tube.Subsequent auto-dilutions were pipetted and processed from vista small sample container (ssc) cups.The customer also processed the sample with 1:5 and 1:10 manual dilutions and received e541: loci cpm cutoff triggered flags, which indicate a result above the readable limits on the sample being tested.No system or assay non-conformance was identified based on the information provided.The customer stated that no sample was available for further analysis.The cause is unknown.Section h6 has been updated to reflect the hsc conclusion.No further evaluation of the device is required.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® BETA HUMAN CHORIONIC GONADOTROPIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7527121
• Report Number: 2517506-2018-00318
• Device Sequence Number: 11164608
• Product Code: DHA
• UDI-Device Identifier: 00842768015540
• UDI-Public: 00842768015540
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2018

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: 10/05/2018
• Device Catalogue Number: K6430 SMN 10445107
• Device Lot Number: 17278BG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/26/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 05/18/2018
• Supplement Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1