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 2018-01-04 for COAGULATION FACTOR VIII DEFICIENT PLASMA 10446411 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[97477162]
Siemens healthcare diagnostics has determined that the cause of the discordant coagulation factor viii deficient plasma patient results generated on the bcs xp analyzer sn (b)(4) was due to a reagent syringe that required replacement on the system. Once the reagent syringe was replaced, the coagulation factor viii deficient plasma test was rerun on the bcs xp analyzer sn (b)(4) and the results generated were acceptable. 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
[97477163]
Discordant coagulation factor viii deficient plasma patient results for one patient were generated on the bcs xp analyzer (sn (b)(4)). These results were not reported to the physician. All quality control (qc) was in range on this bcs xp analyzer. The same patient sample was repeated on the same bcs xp analyzer and discordant coagulation factor viii deficient plasma patient results were generated once again. No discordant results were reported to the physician. The same patient sample was then run on a ca-7000 analyzer and on a different bcs xp analyzer (sn (b)(4)). The coagulation factor viii deficient plasma patient results generated on the ca-7000 analyzer were not considered discordant (mean of 34. 2%) and consistent with the patient results generated on the bcs xp analyzer sn (b)(4) (mean of 33. 2%). The coagulation factor viii deficient plasma patient result generated on the bcs xp analyzer sn (b)(4) (mean of 33. 2%) was reported to the physician. There are no reports of patient intervention or adverse health consequence due to the discordant coagulation factor viii deficient plasma patient results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00003 |
| MDR Report Key | 7165793 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-04 |
| Date of Report | 2018-01-04 |
| Date of Event | 2017-12-09 |
| Date Mfgr Received | 2017-12-09 |
| Device Manufacturer Date | 2016-11-03 |
| Date Added to Maude | 2018-01-04 |
| 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 | 3 |
| Brand Name | COAGULATION FACTOR VIII DEFICIENT PLASMA |
| Generic Name | COAGULATION FACTOR VIII DEFICIENT PLASMA |
| Product Code | GJT |
| Date Received | 2018-01-04 |
| Catalog Number | 10446411 |
| Lot Number | 547642A |
| Device Expiration Date | 2018-10-20 |
| 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 | 2018-01-04 |