MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH PFA-100 SYSTEM

Model Number	PFA-100 SYSTEM
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inconsistent platelet function assay (pfa) - epinephrine (epi) and adenosine diphosphate (adp) results were obtained on a patient sample on a pfa-100 system.Siemens is investigating the issue.
Event or Problem Description
On (b)(6) 2019, inconsistent platelet function assay (pfa) - epinephrine (epi) results were obtained on a patient sample on a pfa-100 system (sn:(b)(4)) using the epi (lot#5695478) reagent cartridge.The sample was initially split between two tubes and both tubes were tested for epi resulting above the lab's normal reference range.Only the second tube was tested for adenosine diphosphate (adp) resulting above the lab's normal reference range.The samples were sent to an alternate lab for repeat testing of both epi and adp, and the results were also above the lab's normal reference range.The initial results were not reported to the physician(s).The results obtained from the alternate lab were reported to the physician(s) as correct.Adp result was not reported as inconsistent.There are no known reports of patient intervention or adverse health consequences due to the inconsistent epi results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2019-00096 on 13-dec-2019.Additional information (20-jan-2020): siemens healthcare diagnostics inc investigated the issue regarding the inconsistent platelet function assay (pfa) - epinephrine (epi) results obtained on a patient sample on a pfa-100 system using the epi reagent cartridge.For the platelet function assay (pfa), the upper limit cut-off is lot specific and needs to be determined by the customer.However, the customer used the cut-off from the assay instructions for use (ifu) and did not set their lot-specific cut-off for this assay.Sample specific issues also could have contributed to the event, as sample handling issues cannot be ruled out.There was no indication of a potential device problem.The cause of the inconsistent pfa - epi results is unknown.The system is performing according to specifications.No further evaluation of this device is required.

• Brand Name: PFA-100 SYSTEM
• Common Device Name: PFA-100 SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 9469173
• Report Number: 9610806-2019-00096
• Device Sequence Number: 19866167
• Product Code: JOZ
• UDI-Device Identifier: 00842768024870
• UDI-Public: 00842768024870
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K060489
• 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,Followup
• Report Date (Section B): 02/07/2020

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 Model Number: PFA-100 SYSTEM
• Device Catalogue Number: 10444868
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1