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 2018-12-14 for PFA-100 SYSTEM 10444868 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[131499404]
The customer contacted a siemens customer care center and reported that different collagen/epinephrine (col/epi) and collagen/adenosine-5'-diphosphate (col/adp) results were obtained on several patient samples on the pfa-100 system. The customer reported that the system passed self-test before the affected samples were run on the system and that there were no issues with quality controls (qcs). Siemens advised the customer to compare results processed at the same position and to not compare results obtained from position a to position b. The customer indicated that they did not observe the issue when they compared results obtained on samples that were repeated in the same position. Currently, the customer is running the samples on two systems instead of running the samples at different positions on one system. Siemens further investigated the cause of the different results obtained on patient samples and determined that sample integrity issues and pre-analytical variables may contribute to the different col/epi and col/adp results. According to the pfa-100 getting started guide, samples with high sedimentation rates can recover different results in position a compared to position b due to settling of the sample during the incubation period and while the sample in position a is processed. The system is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[131499405]
On (b)(6) 2018, the customer reported that different collagen/epinephrine (col/epi) and collagen/adenosine-5'-diphosphate (col/adp) results were obtained on several patient samples when patient samples were run in duplicate on the pfa-100 system. The customer reported that "normal results" were obtained on the samples when the samples were run in position a, while "greater than (>) results with errors" were obtained on the samples when the samples were run in position b. The customer did not specify the errors that were obtained when the samples were run in position b. The results were not reported to the physician(s). The customer did not provide the patient data. There are no known reports of patient intervention or adverse health consequences due to the different col/epi and col/adp results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00115 |
| MDR Report Key | 8164796 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-12-14 |
| Date of Report | 2018-12-14 |
| Date Mfgr Received | 2018-11-20 |
| Date Added to Maude | 2018-12-14 |
| 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 | 2018-12-14 |
| Model Number | PFA-100 SYSTEM |
| Catalog Number | 10444868 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-12-14 |