MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH BC VON WILLEBRAND REAGENT

Model Number BC VON WILLEBRAND REAGENT

Device Problem Low Test Results (2458)

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

Event Date 01/29/2021

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.A siemens customer service engineer (cse) was dispatched to the customer site.The cse changed the piston of the master valve 1 (mv1) on the sysmex cs-2100i system after noticing air leakage in the valve.However, the customer had not noticed sample probe leakage on the day of the event or afterward.If there were a defect in the mv1 to cause it to remain open, the dilution of samples would have occurred with higher frequency and the probe would have left a noticeable trail of water along its path.No other patient samples were reported to be affected.Specimen collection and sample handling issues cannot be ruled out as potential causes 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 9610806-2021-00030 was also filed for the discordant result obtained on (b)(6) 2021.

Event Description

A discordant, falsely low von willebrand factor activity (vwf ac) result was obtained using an aliquot from a patient sample on a sysmex cs-2100i system using bc von willebrand reagent.The discordant result was reported to the physician(s).A second aliquot was created from the same patient sample on the same day, but was not run.The next month, the patient returned to the hospital and was redrawn and retested for vwf ac, which resulted higher than the result from the previous month.This higher result was reported as the correct result to the physician(s).The two aliquots from the previous month were then repeated for vwf ac.The first aliquot again recovered falsely low, while the result from the second aliquot matched the higher result from the newly drawn sample.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low von willebrand factor activity (vwf ac) results.

• Brand Name: BC VON WILLEBRAND REAGENT
• Type of Device: BC VON WILLEBRAND 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 ; 9144153450
• MDR Report Key: 11557210
• MDR Text Key: 247563942
• Report Number: 9610806-2021-00029
• Device Sequence Number: 1
• Product Code: GGP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K972116
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2022
• Device Model Number: BC VON WILLEBRAND REAGENT
• Device Catalogue Number: 10446425
• Device Lot Number: 557481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2021
• 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: 55 YR