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 Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that they obtained elevated col/epi and col/adp results on patient samples and quality controls (qcs).The customer indicated that the error message "maximum test time exceeded" was triggered by the system.The customer reported an incident where they obtained different results on control donors, depending on the cuvette position used to process the sample.Siemens is investigating the issue.Mdrs 9610806-2018-00058, 9610806-2018-00059, 9610806-2018-00060, 9610806-2018-00061, 9610806-2018-00062, 9610806-2018-00064, 9610806-2018-00065, 9610806-2018-00066, 9610806-2018-00067, 9610806-2018-00068, 9610806-2018-00069, 9610806-2018-00070, 9610806-2018-00071, 9610806-2018-00072, and 9610806-2018-00073 were filed for the same event.
Event or Problem Description
The customer reported that elevated collagen/ epinephrine (col/epi) and collagen/ adenosine-5'-diphosphate (col/adp) results were obtained on multiple patient samples on the pfa-100 system for several days.The elevated results were reported to the physician(s) and some physician(s) questioned the elevated results.It is unknown if the results provided by the customer were discordant and the results reported to the physician(s) are unknown.The customer did not provide the correct results for the patients impacted and reported that they did not provide correct results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to elevated col/epi and col/adp results obtained on the patient samples.
Event or Problem Description
The customer clarified that the results in of the initial mdr were reported to the physician(s).
Additional Manufacturer Narrative
Additional information (12-july-2018): the initial mdr indicated that the results reported to the physician(s) were unknown.The customer clarified that the results of the initial mdr were reported to the physician(s).The customer indicated that there were no mechanical errors on the system at the time of the event and that they ran patient samples after the system passed self-tests.The customer also re-calibrated pipettes, tested new cartridges and ruled out sample and reagent handling issues.The customer attributed the cause of the elevated results to the age of the affected system and decided to replace the pfa-100 system with a new system.Siemens further investigated the data and determined that there was no indication that the patient results were discordant.While the elevated quality control recoveries suggested a system issue, there was no indication that a system or reagent malfunction contributed to the elevated col/epi and col/adp results.The cause of the elevated col/epi and col/adp results is unknown.The result code and conclusion code of section h6 were updated to reflect the additional information.No further evaluation of this device is required.Mdrs 9610806-2018-00058_s1, 9610806-2018-00059_s1, 9610806-2018-00060_s1, 9610806-2018-00061_s1, 9610806-2018-00062_s1, 9610806-2018-00064_s1, 9610806-2018-00065_s1, 9610806-2018-00066_s1, 9610806-2018-00067_s1, 9610806-2018-00068_s1, 9610806-2018-00069_s1, 9610806-2018-00070_s1, 9610806-2018-00071_s1, 9610806-2018-00072_s1, and 9610806-2018-00073_s1 were filed for the same event.

• 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: 7689192
• Report Number: 9610806-2018-00063
• Device Sequence Number: 11408226
• Product Code: JOZ
• UDI-Device Identifier: 00842768024870
• UDI-Public: 00842768024870
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/07/2018

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
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 07/16/2018
• Supplement Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1