MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN FSL ACTIVATED PTT REAGENT

Model Number	DADE ACTIN FSL ACTIVATED PTT REAGENT
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).At the time of running the three american proficiency institute (api) surveys, quality controls (qc) recovered either at the upper end or outside the upper end of the quality assurance program (qap) peer range specific for labs using the sysmex ca-620 system and dade actin fsl activated ptt reagent.A siemens technical application specialist (tas) was dispatched to the customer site.The tas discovered that the activated partial thromboplastin time (aptt) test protocol settings on the customer's sysmex ca-620 system were not set for "ptt fsl", even though they were using actin fsl activated ptt reagent.As per the sysmex ca-600 reference guide, ptt test protocol should be set for "ptt fsl" when using this reagent.The customer was using actin reagent in the past, but it is unknown when they changed to actin fsl reagent.The tas measured samples and controls using dade actin fsl activated ptt reagent with the incorrect ptt-actin test protocol (ptt act) and the correct ptt-actin fsl test protocol (ptt fsl).There was a positive bias for ptt act compared to ptt fsl.Qc ran with the ptt fsl protocol recovered within specifications and all precision results recovered within the coefficient of variation specification of 2%.The tas has updated the system with the correct ptt fsl test protocol settings.The customer is going to establish and verify qc ranges, reference ranges, measure survey samples and perform correlation studies with an outside lab before they start measuring aptt again.The cause of the event is use error due to the incorrect ptt test protocol settings used to measure samples with dade actin fsl activated ptt reagent.The reagent is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer has reported that their lab had failed three american proficiency institute (api) surveys for activated partial thromboplastin time (aptt) on a sysmex ca-620 system using dade actin fsl activated ptt reagent.Due to failing three surveys, the customer has had to send samples out to an alternate lab to be tested for aptt.It is unknown if any discordant patient aptt results have been obtained due to this issue.There are no reports of patient intervention or adverse heath consequences due to this event.

• Brand Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Common Device Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 10777961
• Report Number: 9610806-2020-00053
• Device Sequence Number: 3814331
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: 00842768003882
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K863594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 11/03/2020

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: No Information
• Device Expiration Date: 10/23/2020
• Device Model Number: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Device Catalogue Number: 10445714
• Device Lot Number: 556960A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1