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 2019-12-13 for PFA-100 SYSTEM 10444868 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[170793675]
Inconsistent platelet function assay (pfa) - epinephrine (epi) and adenosine diphosphate (adp) results were obtained on a patient sample on a pfa-100 system. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[170793676]
On (b)(6) 2019, inconsistent platelet function assay (pfa) - epinephrine (epi) results were obtained on a patient sample on a pfa-100 system (sn:(b)(4)) using the epi (lot#5695478) reagent cartridge. The sample was initially split between two tubes and both tubes were tested for epi resulting above the lab's normal reference range. Only the second tube was tested for adenosine diphosphate (adp) resulting above the lab's normal reference range. The samples were sent to an alternate lab for repeat testing of both epi and adp, and the results were also above the lab's normal reference range. The initial results were not reported to the physician(s). The results obtained from the alternate lab were reported to the physician(s) as correct. Adp result was not reported as inconsistent. There are no known reports of patient intervention or adverse health consequences due to the inconsistent epi results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2019-00096 |
| MDR Report Key | 9469173 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-12-13 |
| Date of Report | 2020-02-07 |
| Date of Event | 2019-11-18 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2019-12-13 |
| 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 | CHRISTOPHER AEBIG |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242740 |
| Manufacturer G1 | BIT ANALYTICAL INSTRUMENTS GMBH |
| Manufacturer Street | REGISTRATION NUMBER: 300360107 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 | 2019-12-13 |
| Model Number | PFA-100 SYSTEM |
| Catalog Number | 10444868 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-12-13 |