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

Model Number	INNOVANCE D-DIMER
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality control (qc) data was not provided for 24-jun-2020.Qc recovered within acceptable ranges on 25-jun-2020.Siemens discussed with the customer the option of performing a 1:4 offline dilution using d-dimer diluent to confirm results.No system issue was identified.Siemens is investigating the issue.Mdr 9610806-2020-00033 was filed for the discordant d-dimer result obtained on 24-jun-2020.
Event or Problem Description
A discordant d-dimer result was obtained on a patient sample on a sysmex ca-660 system using innovance d-dimer reagent.The discordant result was reported to the physician(s).Prior to obtaining the discordant result, the sample was run for d-dimer twice on the sysmex ca-660 system using innovance d-dimer reagent, but the system did not yield numeric results and generated measurement error flags.The following day, the same sample was repeated for d-dimer on the same sysmex ca-660 system using innovance d-dimer reagent, resulting lower.This result was also considered discordant and was not reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant d-dimer results.
Additional Manufacturer Narrative
The initial mdr 9610806-2020-00034 on 20-jul-2020.Additional information (21-jul-2020): siemens investigation determined that no mechanical errors occurred at the time of the event and the instrument exhibited acceptable precision.The issue was isolated to one patient sample.Reagent handling or sample handling issues such as inadequate mixing or centrifugation cannot be ruled out.Inadequate mixing can lead to discordant results due to uneven anticoagulant dispersal, microclots, or latent fibrin formation in the plasma portion of the sample.Siemens explained to the customer that for future samples the customer should perform an offline dilution to confirm the result.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2020-00033_s1 was filed for the same issue.Sections b5 and b6 were updated to indicate that the d-dimer+ (ddi+) application was used to obtain the d-dimer result of <3.65 mg/l.
Event or Problem Description
A discordant d-dimer result was obtained on a patient sample using the d-dimer+ (ddi+) application on a sysmex ca-660 system using innovance d-dimer reagent.The discordant result was reported to the physician(s).Prior to obtaining the discordant result, the sample was run for ddimer twice on the sysmex ca-660 system using innovance d-dimer reagent, but the system did not yield numeric results and generated measurement error flags.The following day, the same sample was repeated for d-dimer on the same sysmex ca-660 system using innovance d-dimer reagent, resulting lower.This result was also considered discordant and was not reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant d-dimer results.

• Brand Name: INNOVANCE D-DIMER
• Common Device Name: INNOVANCE D-DIMER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 10295865
• Report Number: 9610806-2020-00034
• Device Sequence Number: 2964460
• Product Code: DAP
• UDI-Device Identifier: 00842768022814
• UDI-Public: 00842768022814
• Combination Product (Y/N): N
• 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): 08/14/2020

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: 09/15/2021
• Device Model Number: INNOVANCE D-DIMER
• Device Catalogue Number: 10445981
• Device Lot Number: 49975
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR