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

Model Number INNOVANCE D-DIMER

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered in range at the time of the event.The reaction kinetics were correctly evaluated by the system software.No samples from other patients were affected.Differences between the siemens and non-siemens d-dimer methods, such as different sensitivities to hama antibodies, cannot be ruled out as a potential cause of the event.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.Mdr 9610806-2020-00068 was filed for the potentially discordant results obtained on 01-dec-2020.

Event Description

A negative d-dimer result was obtained on a patient sample on a sysmex cs-2500 system using innovance d-dimer reagent.The result was reported to the physician(s).The patient was initially tested for d-dimer in a private laboratory, giving a positive result.The sample was also sent to another laboratory to be tested for d-dimer, also giving a positive result.The positive results were also reported to the physician(s).Five days later, the patient was again tested for d-dimer on a sysmex cs-2500 system using innovance d-dimer reagent, giving a negative result.The sample was then repeated four more times for d-dimer in microsample mode using different dilutions on two different sysmex cs-2500 systems, each time recovering negative.These negative d-dimer results were also reported to the physician(s).It is unknown which d-dimer results were considered correct.There are no reports of patient intervention or adverse health consequences due to the discordant d-dimer results.

• Brand Name: INNOVANCE D-DIMER
• Type of Device: INNOVANCE D-DIMER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145242740
• MDR Report Key: 11065183
• MDR Text Key: 225141237
• Report Number: 9610806-2020-00067
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: AN
• PMA/PMN Number: K093626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/23/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2022
• Device Model Number: INNOVANCE D-DIMER
• Device Catalogue Number: 10445979
• Device Lot Number: 50579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 73 YR