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 2019-11-19 for PFA-100 SYSTEM 10444868 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[175420972]
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.
Patient Sequence No: 1, Text Type: N, H10
[175420973]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2019-00087 |
| MDR Report Key | 9341276 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-11-19 |
| Date of Report | 2019-11-19 |
| Date of Event | 2019-10-23 |
| Date Mfgr Received | 2019-10-24 |
| Date Added to Maude | 2019-11-19 |
| 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 | 2019-11-19 |
| 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 | 2019-11-19 |