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

Model Number	PFA-100 SYSTEM
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).The customer has replaced the o-ring, the cleaning pad, and the trigger solution on the pfa-100 system.The black parking seal was in tact and not deteriorated.The customer is planning to send the pfa-100 system for repairs.Siemens is investigating the issue.
Event or Problem Description
Two discordant, falsely elevated platelet function assay collagen-epinephrine (pfa col epi) results and two discordant, falsely elevated platelet function assay collagen-adenosine diphosphate (pfa col adp) results were obtained on a patient sample on a pfa-100 system (serial number: 2174).The results were flagged with "maximum test time exceeded" flags.The discordant results were reported to the physician(s).A new sample from the same patient was run for pfa col epi and pfa col adp on an alternate pfa-100 system, both resulting lower.The repeat results were reported, as the correct results, to the physician(s).A discordant, falsely elevated pfa col epi result and a discordant, falsely elevated pfa col adp result were obtained on another sample from a different patient.The results were flagged with "maximum test time exceeded" flags.The discordant results were reported to the physician(s).The same sample was repeated for pfa col epi and pfa col adp on an alternate pfa-100 system, both resulting lower.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated pfa col epi and pfa col adp results.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2021-00063 on 20-sep-2021.Additional information (03-nov-2021): the customer's pfa-100 system was sent to siemens for repairs.Siemens service performed a preventative maintenance, lubricated the syringe, replaced the o-ring, parking seal, syringe pump motor, carousel cover and reflective pads, keypad printer and printer pcb, solenoid pump, power supply, vacuum tubing, and air tubing, and aligned and verified the code sensor and trigger dispense tube.The service report indicated that the failure found was a faulty syringe pump motor.The system was operational after being returned to the customer.The cause of the event was a faulty syringe pump motor.Sections h3 and h6 were updated to reflect the additional information.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
• Manufacturer (Section G): BIT ANALYTICAL INSTRUMENTS GMBH; registration number: 300360107; am kronberger hang 3; schwalbach, 65824 ; GM 65824
• Manufacturer Contact: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9144153450
• MDR Report Key: 12497059
• Report Number: 9610806-2021-00063
• Device Sequence Number: 3439273
• Product Code: JOZ
• UDI-Device Identifier: 00842768024870
• UDI-Public: 00842768024870
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K060489
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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: Health Professional
• Device Model Number: PFA-100 SYSTEM
• Device Catalogue Number: 10444868
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown