MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH INNOVANCE D-DIMER

Model Number	INNOVANCE D-DIMER
Medical Device Problem Codes	Off-Label Use (1494); Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) to report that a discordant, falsely low d-dimer result was obtained on a patient sample on a sysmex ca-1500 system using the innovance d-dimer reagent.The customer properly filled the sample, it was not lipemic, icteric or hemolyzed.Siemens determined that quality controls (qcs) were within expected ranges on the day of event.Siemens determined that inadequate mixing, centrifuging or other sample handling issues could be the contributing factors to the discordant result.Inadequate sample mixing can lead to erroneous results due to micro clots or latent fibrin formation in the plasma portion of the sample.The customer did not report issues with any other assays on this instrument.The cause of the discordant, falsely low d-dimer result is unknown.The reagent is performing according to specifications.No further evaluation of the device is required.
Event or Problem Description
A discordant, falsely low d-dimer result was obtained on a patient sample when the sample was diluted and repeated on a sysmex ca-1500 system, using the innovance d-dimer reagent.When the sample was initially run, a higher d-dimer result was obtained on the patient sample.The discordant result was reported to the physician(s) and recalled before the physician(s) saw the result.The sample was repeated multiple times on the same system under different sample ids, resulting higher.The repeat result of 4.09 was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low d-dimer result.
Additional Manufacturer Narrative
Additional information (29-oct-2018): a siemens customer service engineer (cse) was dispatched to the customer's site.During this visit, the cse ran a precision study and quality controls on the sysmex ca-1500 system; the precision study and quality controls recoveries were within expected ranges.Siemens further investigated the issue and determined that the customer was using reaction cuvettes that were not validated by siemens on the sysmex ca-1500 system.Siemens cannot determine if the use of these cuvettes contributed to the discordant, falsely low d-dimer result; the customer indicated that they are in the process of converting the non-validated reaction cuvettes with validated reaction cuvettes.Siemens also determined that there were no mechanical errors on the day of the event.The cause of the discordant, falsely low d-dimer result is unknown.The reagent is performing according to specifications.No further evaluation of the device is required.

• Brand Name: INNOVANCE D-DIMER
• Common Device Name: INNOVANCE D-DIMER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH; emil-von-behring-str 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 8039059
• Report Number: 9610806-2018-00114
• Device Sequence Number: 1187906
• Product Code: DAP
• UDI-Device Identifier: 00842768022814
• UDI-Public: 00842768022814
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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: 11/05/2019
• Device Model Number: INNOVANCE D-DIMER
• Device Catalogue Number: 10445981
• Device Lot Number: 48194
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 11/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR