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

Model Number INNOVANCE D-DIMER REAGENT

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and reported that the innovance d-dimer controls were recovering outside of package insert range on the sysmex ca-660 system.In addition, it was found that the quality control (qc) range being used did not match the qc range listed on the table of assigned values (tav) for the qc batch being used and patient results were reported while qc was out of range.The customer resolved the issue by making fresh reagent, preparing new qc and updating the qc range per the tav for the batch in use.The system was restarted, and qc then recovered within range.Based on the available information, user error is the probable cause for reporting patient results when qc was out of the lot specific innovance d-dimer table of assigned values (tav).The probable cause for the qc results being out of range is likely due to mishandling of the reagents and using an incorrect qc range.Per the sysmex ca 500/ca 600 system reference guide usa only version 4.01 the innovance d-dimer states that in the original vials, the reagents may be left on board the instrument continuously for 16 hours or stored on and off the instrument for intervals of 7 × 1 hour over a maximum period of 14 days.The customer was unaware of the interval hours the reagent could be out of the refrigerator and was only abiding by the maximum period of 14 days.Over the course of multiple lot use the customer was not updating the correct qc range on the instrument.There is no suspected malfunction or systemic product problem with either the instrument or reagents.The unique device identifier number for the innovance d-dimer reagent was not available at the time of filing this mdr.The controls are performing according to specifications.No further investigation of this device is required.Mdr 9610806-2019-00079 was filed for additional patient results that were reported while innovance d-dimer qc was out of range at this site.

Event Description

Patient d-dimer results were obtained on a sysmex ca-660 system using innovance d-dimer reagent and were reported while quality controls (qc) were out of range.The results were not questioned by the physician(s).It is unknown if the results were considered discordant.There are no known reports of patient intervention or adverse health consequences due to this event.

• Brand Name: INNOVANCE D-DIMER REAGENT
• Type of Device: INNOVANCE D-DIMER REAGENT
• 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: 9252289
• MDR Text Key: 165138770
• Report Number: 9610806-2019-00080
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/13/2021
• Device Model Number: INNOVANCE D-DIMER REAGENT
• Device Catalogue Number: 10445981
• Device Lot Number: 49312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2019
• 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