MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; DIMENSION® AMY AMYLASE FLEX® REAGENT CARTRIDGE

Catalog Number	DF17A SMN 10444965
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2018-00260 was also filed for the same amy event.The customer contacted siemens customer care center (ccc) and reported that a discordant, falsely elevated amylase (amy) patient result was obtained on the dimension rxl max hm system.Siemens is investigating the incident.
Event or Problem Description
A discordant, falsely elevated amylase (amy) result was obtained on a patient sample on the dimension rxl max hm system.The result was reported to the physician who questioned the result.The same sample was tested on the same instrument at a later date and an elevated result was obtained.The patient was hospitalized for suspected pancreatitis.There are no reports of patient intervention or adverse health consequences due to the discordant elevated amy result.
Additional Manufacturer Narrative
Original mdr(b)(6) 2018.(additional information 21-may-2018) siemens headquarters support center (hsc) evaluated instrument data logs and the available information.The customer confirmed that no medical procedure was performed on the patient nor treatment modified based upon the discordant elevated amylase (amy) result.Instrument daily system checks displayed no atypical performance.Amy calibration data was within conformance at the time of the event.Quality control results were reported as recovering within the customer established ranges.A customer service engineer was dispatched to the site and did not identify any instrument malfunctions.Hsc concluded that no product non-conformance was identified.The cause is unknown.The device is operating within specifications.No further investigation is required.Section h6 has been updated to reflect the hsc conclusion.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® AMY AMYLASE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• MDR Report Key: 7427108
• Report Number: 2517506-2018-00258
• Device Sequence Number: 16441816
• Product Code: JFJ
• UDI-Device Identifier: 00842768005404
• UDI-Public: 00842768005404
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K942640
• 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): 06/13/2018

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: 10/26/2018
• Device Catalogue Number: DF17A SMN 10444965
• Device Lot Number: EA8299
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1