MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-08-31 for PFA-100 SYSTEM 10444868 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[119048864]
The customer contacted a siemens customer care center and reported that discordant, falsely elevated collagen/epinephrine (col/epi) results were obtained on patient samples on the pfa-100 system. The customer refused to send the system to siemens for service or further investigation and continued to run patient samples for pre-surgery screenings on the system. The customer indicated that the issue is sporadic; when they obtain elevated results, they rerun the sample and obtain lower results. The customer suspects that sample specific issues, such as bubbles in the samples, potentially contributed to the elevated col/epi results. The cause of the discordant, falsely elevated col/epi results is unknown. No further evaluation of this device is required. Mdr 9610806-2018-00085, mdr 9610806-2018-00086, mdr 9610806-2018-00087, mdr 9610806-2018-00088, and mdr 9610806-2018-00090 were filed for the same issue.
Patient Sequence No: 1, Text Type: N, H10
[119048865]
A discordant, falsely elevated collagen/epinephrine (col/epi) result was obtained on a patient sample on a pfa-100 system. The discordant result was not reported to the physician(s). The sample was repeated on the same system and the same result was obtained. It is unknown if the repeat result was reported to the physician(s). The customer reported that discordant, falsely elevated col/epi results of >300 seconds were obtained on other patient samples. When the samples were repeated on the same system, lower results were obtained. The customer reported the lower results to the physician(s). The customer did not provide data for all patients impacted by this event. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated col/epi results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00089 |
| MDR Report Key | 7839620 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-31 |
| Date of Report | 2018-09-28 |
| Date of Event | 2018-07-09 |
| Date Mfgr Received | 2018-09-03 |
| Date Added to Maude | 2018-08-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | BIT ANALYTICAL INSTRUMENTS GMBH |
| Manufacturer Street | REGISTRATION NUMBER:3003601075 AM KRONBERGER HANG 3 |
| Manufacturer City | SCHWALBACH 65824 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65824 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PFA-100 SYSTEM |
| Generic Name | PFA-100 SYSTEM |
| Product Code | JOZ |
| Date Received | 2018-08-31 |
| Model Number | PFA-100 SYSTEM |
| Catalog Number | 10444868 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-31 |