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

Model Number	ENZYMATIC CREATININE_2 REAGENTS (ECRE_2)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center.The customer repeats all serum ecre_2 results greater than 20 mg/l.A siemens headquarters support center (hsc) specialist reviewed the data and stated that the patient samples were historically running at >20 mg/l.Advia chemistry 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 technical operations specialist discussed the issue with the hsc specialist and the customer was informed that the issue is rare as not all igm antibodies interfere, only certain clones do.Also the reaction that causes the interference is not consistent.The same sample which shows the interference may not consistently show the interference in replicate testing.To proactively detect the gammapathy interference, the customer was advised to dilute the sample and use alternate testing (jaffe creatinine_2).The hsc specialist stated that monoclonal gammopathy interference may have caused the issue.The cause of the discordant, falsely elevated ecre_2 result on one patient sample is unknown.The device is performing within manufacturing specifications.No further evaluation of device is required.
Event or Problem Description
A discordant, falsely elevated enzymatic creatinine_2 (ecre_2) result was obtained on one patient sample on an advia chemistry xpt instrument when using reagent lot 50349.The same sample was tested for jaffe creatinine_2 (crea_2) on the same instrument, resulting as expected.The discordant result was reported to the physician(s), and questioned.The correct crea_2 result was also reported to the physician(s).The patient underwent biopsy and an inscription to a kidney implant protocol due to the discordant, falsely elevated ecre_2 result.The sample was diluted with a dilution factor of 1:4 and run on the same instrument, also resulting lower for ecre_2.There are no reports of adverse health consequence due to the discordant, falsely elevated ecre_2 result.
Additional Manufacturer Narrative
The initial mdr 2432235-2017-00562 was filed on october 24, 2017.Corrected information (10/27/2017): the initial mdr stated, "the patient underwent biopsy and an inscription to a kidney implant protocol due to the discordant, falsely elevated ecre_2 result." the correct information was received indicating that the patient was not registered for the kidney transplant protocol.Been updated with this information.The initial mdr stated "to proactively detect the gammapathy interference, the customer was advised to dilute the sample and use alternate testing (jaffe creatinine_2)." the correct information was received indicating that setting up the (jaffe creatinine_2) was a costumer initiative and request to be able to anticipate interferences and perform impact studies.Updated with this information.
Event or Problem Description
A discordant, falsely elevated enzymatic creatinine_2 (ecre_2) result was obtained on one patient sample on an advia chemistry xpt instrument when using reagent lot 50349.The same sample was tested for jaffe creatinine_2 (crea_2) on the same instrument, resulting as as expected.The discordant result was reported to the physician(s), and questioned.The correct crea_2 result was also reported to the physician(s).The patient underwent renal biopsy due to the discordant, falsely elevated ecre_2 result.The sample was diluted with a dilution factor of 1:4 and run on the same instrument, also resulting lower for ecre_2.There are no reports of adverse health consequence due to the discordant, falsely elevated ecre_2 result.

• Brand Name: ENZYMATIC CREATININE_2 REAGENTS (ECRE_2)
• Common Device Name: ENZYMATIC CREATININE_2 REAGENTS (ECRE_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 6971197
• Report Number: 2432235-2017-00562
• Device Sequence Number: 1227678
• Product Code: JFY
• UDI-Device Identifier: 00630414526690
• UDI-Public: 00630414526690
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K070727
• 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): 11/20/2017

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 Model Number: ENZYMATIC CREATININE_2 REAGENTS (ECRE_2)
• Device Catalogue Number: 10335869
• Device Lot Number: 50349
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 10/24/2017
• Supplement Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR