MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-22 for FACTOR VIII CHROMOGENIC ASSAY 10445729 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[93690156]
Siemens healthcare diagnostics has investigated the provided information to determine the cause of the discordant, high factor viii activity patient result on the bcs xp system. No product non-conformance could be identified and all information that was provided indicates a possible sample specific issue. The instrument and reagent are performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[93690157]
A discordant, high factor viii activity patient result (chromogenic factor viii assay) was generated on the bcs xp system compared to a chromogenic factor viii activity patient result generated at another reference lab (esoterix). A different patient sample (from the same patient) was used at esoterix, but it is not known what system was used. Quality controls were in range. There are no reports of patient intervention or adverse health consequence due to the discordant, high factor viii activity patient result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00135 |
| MDR Report Key | 7053619 |
| Date Received | 2017-11-22 |
| Date of Report | 2017-11-22 |
| Date of Event | 2017-10-15 |
| Date Mfgr Received | 2017-10-27 |
| Device Manufacturer Date | 2016-03-24 |
| Date Added to Maude | 2017-11-22 |
| 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 | LORIANN RUSSO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242287 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL VON BEHRING STRASSE 76 |
| Manufacturer City | MARBURG, 35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FACTOR VIII CHROMOGENIC ASSAY |
| Generic Name | FACTOR VIII CHROMOGENIC ASSAY |
| Product Code | GGP |
| Date Received | 2017-11-22 |
| Catalog Number | 10445729 |
| Lot Number | 529391 |
| Device Expiration Date | 2018-02-07 |
| 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 STRASSE 76 MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-22 |