MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® PRL PROLACTIN FLEX® REAGENT CARTRIDGE

Catalog Number	K6462 SMN10488398
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) reporting a discordant prolactin (prl) result obtained on the dimension vista instrument.Siemens headquarters support center (hsc) has reviewed the data for the prolactin (prl) dilutions.No product nonconformance was identified.The event was a use error with manual dilutions on the first sample tested.Manual dilutions were not prepared however the customer entered a manual dilution factor into the test orders in error.No product nonconformance was identified.No further evaluation of the device is required.
Event or Problem Description
A prolactin (prl) result was reported on a patient sample on the dimension vista 1500 instrument and questioned by the physician as the result was lower than expected.The same sample was repeated the following day confirming the initial result.Customer reported performing serial dilutions after the physician questioned the initial result.Dilution factors were entered in the instrument but no manual dilutions were performed on the sample prior to testing which produced higher results.A new sample was drawn and serial dilutions were performed correctly at a later date.The serial dilutions recovered as expected when compared to the initial patient sample.There are no reports of patient intervention or adverse health consequences due to the discordant prl results.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® PRL PROLACTIN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7567156
• Report Number: 2517506-2018-00338
• Device Sequence Number: 1555704
• Product Code: CFT
• UDI-Device Identifier: 00842768026454
• UDI-Public: 00842768026454
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 06/04/2018

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: 11/30/2018
• Device Catalogue Number: K6462 SMN10488398
• Device Lot Number: 17334BB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1