MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION®; SIROLIMUS FLEX® REAGENT CARTRIDGE

Catalog Number	DF306 SMN 10464331
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 2517506-2019-00181 was filed for the same event.The customer contacted the siemens customer care center (ccc) and reported a discordant depressed sirolimus (siro) patient result obtained on the dimension exl with lm instrument.Siemens is investigating the event.
Event or Problem Description
A discordant depressed sirolimus (siro) result was obtained on a patient sample on a dimension exl with lm instrument.The result was reported to the physician (s).A diluted sample from the same patient was processed with the same instrument and higher results were obtained.There are no known reports of patient intervention or adverse health consequences due to the discordant depressed siro result.
Additional Manufacturer Narrative
Initial mdr 2517506-2019-00182 was filed on 26-apr-2019.Additional information (09-may-2019): siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant falsely depressed sirolimus (siro) result.The patient with the discrepant result was on several other medications in addition to sirolimus.These other drugs included tacrolimus and the antibiotics rifampicin/rifampin and amoxicillin/clavulanic acid.Hsc has reviewed the information provided.Hsc requested additional data in order to perform a more in depth investigation however this data was not provided.The cause of this event is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Supplemental mdr (b)(4) was filed for the same event.

• Brand Name: DIMENSION®
• Common Device Name: SIROLIMUS FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. bos 6101; newark DE 19714 6101
• MDR Report Key: 8555374
• Report Number: 2517506-2019-00182
• Device Sequence Number: 14208327
• Product Code: NRP
• UDI-Device Identifier: 00842768022111
• UDI-Public: 00842768022111
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K081857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: 11/01/2019
• Device Catalogue Number: DF306 SMN 10464331
• Device Lot Number: BB9305
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1