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	07/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered within range and no instrument errors occurred at the time of the event.The issue was isolated to these patient samples from the same patient only.Siemens explained to the customer that for future samples the customer should perform either a 1/2 or 1/4 offline manual dilution using d-dimer diluent to confirm the result.The cause of the discordant result(s) is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
A d-dimer result was obtained on a patient sample on a sysmex ca-660 system using innovance d-dimer reagent.The customer reran the sample for d-dimer using the d-dimer+ (ddi+) application with the same system and reagent, recovering lower.A second sample from the same patient was run for d-dimer using the same system and reagent, recovering higher.The redrawn sample was repeated again for d-dimer using the ddi+ application with the same system and reagent, recovering lower.The higher d-dimer result was reported to the physician(s).It is unknown which d-dimer result was considered correct.There are no reports of patient intervention or adverse health consequences due to the discordant d-dimer result(s).

• 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: 10404576
• Report Number: 9610806-2020-00038
• Device Sequence Number: 16874760
• 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
• Report Date (Section B): 08/13/2020

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: 12/01/2021
• Device Model Number: INNOVANCE D-DIMER
• Device Catalogue Number: 10445981
• Device Lot Number: 50233
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1