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

Model Number	PFA-100 SYSTEM
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).There were no visible issues with the cartridges in question.A mix-up of adp and epi type code sensor calibration can be excluded since the issue is sporadic and not permanent.The customer did not report specific error codes, so a misalignment of the pfa-100 system type code sensor can be excluded, as it would trigger error codes.Siemens recommended checking that no foil residues are blocking the holes on the cartridges.Siemens also recommended sending the pfa-100 system to a repair shop according to local service contracts.The cause of the event is unknown.No further evaluation of this device is required.The customer did not provide specific dates of event when the issue occurred.The issue has been occurring intermittently since the beginning of the year.
Event or Problem Description
The customer reported that adenosine diphosphate (adp) cartridges were intermittently being read as epinephrine (epi) on their pfa-100 system.No discordant results were reported to the physician(s).The customer repeated the affected samples with a new adp cartridge and reported out these repeat results, as the correct results, to the physician(s).There are no reports of patient intervention or adverse health consequences due to this issue.

• 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: 10119745
• Report Number: 9610806-2020-00023
• Device Sequence Number: 11629908
• Product Code: JOZ
• UDI-Device Identifier: 00842768024870
• UDI-Public: 00842768024870
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 06/04/2020

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: Health Professional
• Device Model Number: PFA-100 SYSTEM
• Device Catalogue Number: 10444868
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 06/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1