MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-13 for INNOVANCE PFA-200 SYSTEM 10488536 (SEE SECTION H10) manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[111449056]
The customer contacted siemens customer care center and reported that they obtained discordant, falsely elevated collagen/ adenosine-5'-diphosphate (col/adp) and collagen/ epinephrine (col/epi) results on the innovance pfa-200 system. The customer provided the reaction curves for the discordant col/adp and col/epi results. The customer reported that results obtained on the pfa-100 system aligned with the patient's clinical history. Siemens investigated the reaction curves. Siemens determined that cause of the discordant, falsely elevated col/adp and col/epi results was potentially due to a sample specific issue and was potentially related to thrombocyte functionality. The system is performing according to specifications. No further evaluation of this device is required. The innovance pfa-200 system with catalog # 10488536, described, is not marketed in the united states (us) and the pma/510(k) is for the similar pfa-100 system that is marketed in the us. The pfa-100 system has a catalog # of 10444868.
Patient Sequence No: 1, Text Type: N, H10
[111449057]
After the administration of minirin, the patient was tested for collagen/ adenosine-5'-diphosphate (col/adp) and collagen/ epinephrine (col/epi) multiple times. A 30 minutes after the administration of minirin, a sample from the patient was run for col/adp on a pfa-100 system and an innovance pfa-200 system, resulting in a discordant, falsely elevated col/adp result on the innovance pfa-200 system. The sample was also run for col/epi twice; once on the pfa-100 system and the customer did not provide which system was used to obtain the other result. The patient was redrawn 1 hour after the administration of minirin and tested for col/epi and col/adp, resulting in other discordant, falsely elevated col/adp and col/epi results on the innovance pfa-200 system. When this sample was run on the pfa-100 system and a system that the customer did not identify, lower results were obtained. The customer reported that the patient was redrawn hourly after the administration of minirin and provided the results obtained on the samples drawn 2 hours and 3 hours after the administration of minirin. The discordant results obtained on the innovance pfa-200 system were not reported to the physician(s). The results obtained on the pfa-100 system were reported to the physician(s) as the customer reported that these results matched the patient's previous results and medical history. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated col/adp and col/epi results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00051 |
| MDR Report Key | 7598431 |
| Date Received | 2018-06-13 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-05-14 |
| Date Mfgr Received | 2018-05-17 |
| Date Added to Maude | 2018-06-13 |
| 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 |
| 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 | 0 |
| Brand Name | INNOVANCE PFA-200 SYSTEM |
| Generic Name | INNOVANCE PFA-200 SYSTEM |
| Product Code | JOZ |
| Date Received | 2018-06-13 |
| Model Number | INNOVANCE PFA-200 SYSTEM |
| Catalog Number | 10488536 (SEE SECTION H10) |
| 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 | 2018-06-13 |