MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-12-11 for PFA COLLAGEN/EPI 10445696 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[175423630]
The customer contacted a siemens customer care center (ccc) and reported that discordant, falsely low platelet function assay (pfa) - epinephrine (epi) results were obtained on eleven patient samples on an innovance pfa-200 system using pfa collagen/epi reagent. The customer's innovance pfa-200 system had previously been replaced and the vacuum chuck of the innovance pfa-200 system was cleaned, but the issue is still occurring. Mdrs 9610806-2019-00091, 9610806-2019-00093, 9610806-2019-00094, and 9610806-2019-00095 were also filed for the four other dates when the discordant results were obtained. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[175423631]
Discordant, falsely low platelet function assay (pfa) - epinephrine (epi) results were obtained on eleven patient samples on an innovance pfa-200 system using pfa collagen/epi reagent. The results were reported to the physician(s) and were questioned by the physician(s) as the patients were all taking 100 mg of aspirin. There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low platelet function assay (pfa) - collagen epinephrine (col/epi) results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2019-00092 |
| MDR Report Key | 9452062 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-12-11 |
| Date of Report | 2020-02-07 |
| Date of Event | 2019-11-12 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2019-12-11 |
| 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 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL-VON-BEHRING-STR. 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PFA COLLAGEN/EPI |
| Generic Name | PFA COLLAGEN/EPI |
| Product Code | JOZ |
| Date Received | 2019-12-11 |
| Model Number | PFA COLLAGEN/EPI |
| Catalog Number | 10445696 |
| Lot Number | 5695476 |
| Device Expiration Date | 2019-02-19 |
| 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 | 2019-12-11 |