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	10/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc) and reported that a discordant, falsely elevated platelet function assay (pfa) - collagen epinephrine (col/epi) result was obtained on a patient sample on a pfa-100 system using collagen epinephrine reagent.The customer replaced the o-ring on the affected pfa-100 system.Proper sample handling was also discussed with the customer.The customer is planning to compare results on both of their pfa-100 systems using a new lot of collagen epinephrine reagent to further investigate the issue.Siemens is investigating the issue.
Event or Problem Description
A discordant, falsely elevated platelet function assay (pfa) - collagen epinephrine (col/epi) result was obtained on a patient sample on a pfa-100 system using collagen epinephrine reagent.This result was reported to the physician(s).The same sample was then repeated for pfa - col/epi on an alternate pfa-100 system (serial number (b)(4)), resulting lower.The same sample was then repeated again for pfa - col/epi on the initial pfa-100 system also resulting lower and confirming the other repeat result.The repeat result obtained on the alternate pfa-100 system was reported, as the correct result, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated platelet function assay (pfa) - collagen epinephrine (col/epi) result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2019-00087 on 19-nov-2019.Siemens filed the first supplemental mdr 9610806-2019-00087_s1 on 03-mar-2020.Additional information (03-mar-2020): the customer validated the repaired pfa-100 system.The customer was satisfied with the correlation data between the repaired pfa-100 system and the lab's loaner pfa-100 system, and the coefficient of variation percent obtained was acceptable.Additional information (06-mar-2020): siemens healthcare diagnostics inc's investigation has determined that the cause of the discordant, falsely elevated platelet function assay (pfa) - collagen epinephrine (col/epi) result obtained on a patient sample on a pfa-100 system using collagen epinephrine reagent could not be established.Debris from the eroding carousel cover was found to be collecting on the o-ring, preventing a good vacuum seal.However, there is no indication that this finding exceeds normal wear and tear since the time of the previous service performed.Improper mixing of the sample after collection, subsequent sample handling issues prior to testing, and other preanalytical variables could not be excluded.Customer handling of samples and cartridges and operation of the analyzer should be further evaluated if there are further on-going reproducibility issues.The system is performing according to specifications.No further evaluation of this device is required.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2019-00087 on 19-nov-2019.Additional information (12-feb-2020): the customer's pfa-100 system was serviced in april 2019.The customer service engineer (cse) observed that there was debris on the o-ring due to deterioration of the carousel cover cleaning well, the run pad had deteriorated, and the dispense tube was corroded with a side seepage issue.The cse performed the preventive maintenance and replaced the following system parts: the syringe drive motor, the sensor/pump assembly, the keypad, the carousel cover, the anti-reflective pads, the parking seal, the vacuum o-ring, the vacuum tubing, the trigger/ail tubing, and the dispense tube.The cse performed an additional 1646 loop test cycles with no failures.The customer is in process of validating the system.Siemens is investigating the 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: 9341276
• Report Number: 9610806-2019-00087
• Device Sequence Number: 2132707
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2020

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
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 02/12/2020; 03/03/2020
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 03/03/2020; 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1