MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ENZYMATIC CREATININE_2 REAGENTS (ECRE_2)

Model Number ENZYMATIC CREATININE_2 REAGENTS (ECRE_2)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center.The discordant results have been obtained since 2016, as per the patient's history.Since 2017, the customer has implemented a systematic repeat testing for all the ecre_2 result > 20 mg/l with creatinine_2 (jaffe method) on advia chemistry xpt system.The customer suspects the cause of the discordant, falsely elevated ecre_2 results on one patient sample to be due to interference with igm kappa (monoclonal peak on immunoelectrophoresis).Advia chemistry xpt ecre_2 instructions for use under limitations of the procedure section states, "blood samples from some patients with monoclonal gammopathies (for example, waldenstrom's macroglobulinemia) may produce falsely elevated results when using the advia chemistry ecre_2 assays".Therefore patient samples with known monoclonal gammopathies should be used with caution.A siemens headquarters support center (hsc) specialist determined that there was no indication of foaming or mixing issues based on reaction curve.Based on the event information, the issue was resolved by repeating the samples using alternate methods, which confirmed a known sample interference claimed for the assay.The device is performing within manufacturing specifications.No further evaluation of device is required.Mdrs 2432235-2018-00168, 2432235-2018-00169, 2432235-2018-00170, 2432235-2018-00171, 2432235-2018-00172, 2432235-2018-00173, 2432235-2018-00174, 2432235-2018-00175, 2432235-2018-00176, 2432235-2018-00177, 2432235-2018-00178, 2432235-2018-00180, 2432235-2018-00181, and 2432235-2018-00184 were filed for the same event.

Event Description

Discordant, falsely elevated enzymatic creatinine (ecre_2) results were obtained on one patient sample upon initial and repeat testing on an advia chemistry xpt instrument, while using kit lot 503048.The discordant results were reported to the physician(s).Sample ids (b)(6) and (b)(6) were tested using another method creatinine_2 (jaffe method) on the advia chemistry xpt instrument, resulting lower and in agreement with the clinical picture of the patient.Sample id (b)(6) was also tested on an alternate platform, resulting normal.The corrected results were reported to the physician(s).The patient was subjected to two kidney biopsies in 2017 and tested for additional assays for investigation in hospital.The kidney biopsies were done prior to the last discordant results and initiated as the clinician could not explain the elevated ecre_2 results since 2016.There are no known reports of adverse health consequences to the patient due to the discordant ecre_2 results.

Manufacturer Narrative

The initial mdr 2432235-2018-00179 was filed on 26-apr-2018.Corrected information (01-may-2018): the initial mdr indicated that the advia chemistry enzymatic creatinine_2 lot # being affected was 503048.The correct lot # is 50348.Sections b5 and d4 have been updated with this information.Mdrs 2432235-2018-00168_s1, 2432235-2018-00169_s1, 2432235-2018-00170_s1, 2432235-2018-00171_s1, 2432235-2018-00172_s1, 2432235-2018-00173_s1, 2432235-2018-00174_s1, 2432235-2018-00175_s1, 2432235-2018-00176_s1, 2432235-2018-00177_s1, 2432235-2018-00178_s1, 2432235-2018-00180_s1, 2432235-2018-00181_s1, and 2432235-2018-00184_s1 were filed for the same event.

Event Description

Discordant, falsely elevated enzymatic creatinine (ecre_2) results were obtained on one patient sample upon initial and repeat testing on an advia chemistry xpt instrument, while using kit lot 50348.The discordant results were reported to the physician(s).Sample ids n1706060036 and n1982490004 were tested using another method creatinine_2 (jaffe method) on the advia chemistry xpt instrument, resulting lower and in agreement with the clinical picture of the patient.Sample id n1706060036 was also tested on an alternate platform, resulting normal.The corrected results were reported to the physician(s).The patient was subjected to two kidney biopsies in 2017 and tested for additional assays for investigation in hospital.The kidney biopsies were done prior to the last discordant results and initiated as the clinician could not explain the elevated ecre_2 results since 2016.There are no known reports of adverse health consequences to the patient due to the discordant ecre_2 results.

• Brand Name: ENZYMATIC CREATININE_2 REAGENTS (ECRE_2)
• Type of Device: ENZYMATIC CREATININE_2 REAGENTS (ECRE_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 7464412
• MDR Text Key: 107078281
• Report Number: 2432235-2018-00179
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 00630414526690
• UDI-Public: 00630414526690
• Combination Product (y/n): N
• PMA/PMN Number: K070727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENZYMATIC CREATININE_2 REAGENTS (ECRE_2)
• Device Catalogue Number: 10335869
• Device Lot Number: 50348
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR