MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-30 for BERICHROM ANTITHROMBIN III 10446672 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[91227179]
Siemens healthcare diagnostics has investigated the provided information to determine the cause of the discordant, low atiii patient sample result on the atellica coagulation 360 system. No product non-conformance could be identified and a possible cause of the event may be related to sample handling. 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
[91227180]
A discordant, low berichrom antithrombin iii (atiii) patient sample result of <15% was generated on the atellica coag 360 system and was not reported to the physician. The same sample was tested again on the same system and an atiii result of 95. 2% was generated. The same patient sample was repeated on a bcs xp system and an atiii result (not provided by customer) was generated that was consistent with the 95. 2% result on the atellica coag 360 system. All quality control results were within range. There are no reports of patient intervention or adverse health consequence due to the discordant, low atiii result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00119 |
| MDR Report Key | 6986810 |
| Date Received | 2017-10-30 |
| Date of Report | 2017-10-30 |
| Date of Event | 2017-10-05 |
| Date Mfgr Received | 2017-10-05 |
| Device Manufacturer Date | 2017-02-10 |
| Date Added to Maude | 2017-10-30 |
| 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 | BERICHROM ANTITHROMBIN III |
| Generic Name | BERICHROM ANTITHROMBIN III |
| Product Code | JPE |
| Date Received | 2017-10-30 |
| Catalog Number | 10446672 |
| Lot Number | 46999 |
| Device Expiration Date | 2018-11-10 |
| 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 | 2017-10-30 |