MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION®; DIMENSION® EXL RCRP C-REACTIVE PROTEIN EXTENDED RANGE FLEX® REAGENT CARTRIDGE

Catalog Number	DF34 SMN 10444903
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdrs 2517506-2019-00048, 2517506-2019-00050, 2517506-2019-00051, 2517506-2019-00052 and 2517506-2019-00053 were filed for the same event.Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely elevated c-reactive protein (rcrp) result.The customer tested a sample with the siemens rcrp reagent after treatment of the patient sample with nabt (non-specific antibody blocking tubes) and hbt (heterophilic blocking tubes) and obtained rcrp results with 35% and 63% interference attenuation.Per the dimension exl system instructions for use for rcrp: "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay has been designed to minimize interference from heterophilic antibodies.Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed." the cause of the elevated result was determined to be non-specific antibody interference on this patient.No product or system non-conformance identified.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A discordant, falsely elevated c-reactive protein (rcrp) result was obtained on a patient sample on the dimension exl system.The discordant result was reported to the physician who questioned the result.The patient was administered antibiotics.A new sample from the same patient was processed using two alternate methodologies and lower results were obtained.There are no reports of adverse health consequences due to the discordant, elevated rcrp result or due the patient's antibiotic treatment.

• Brand Name: DIMENSION®
• Common Device Name: DIMENSION® EXL RCRP C-REACTIVE PROTEIN EXTENDED RANGE FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; p.o. bos 6101; newark DE 19714 6101
• MDR Report Key: 8304771
• Report Number: 2517506-2019-00049
• Device Sequence Number: 16156573
• Product Code: DCN
• UDI-Device Identifier: 00842768014130
• UDI-Public: 00842768014130
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K003419
• 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
• Report Date (Section B): 02/05/2019

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: 08/02/2019
• Device Catalogue Number: DF34 SMN 10444903
• Device Lot Number: FB9214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1