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 2015-11-23 for FACTOR VIII CHROMOGENIC ASSAY B4238-40 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[31802036]
The cause of the flagged plasma n control results with the f viii reagent lot 44637 is unknown. Root cause investigation has been initiated and is ongoing. Manufacturer's preliminary analysis: during investigations, siemens healthcare diagnostics has observed that the above mentioned lot is showing an increased occurrence of irregular curves when used for measurement on sysmex ca-/cs- instruments. This could lead under certain circumstances to an erroneously increased result with a factor viii chromogenic assay. The use of the affected lot on the bcs/ and bcs xp system is not affected by this issue. Siemens issued an urgent field safety notice br-01216 outside the u. S and an urgent medical device correction communication ph-16-002. A. Us within the u. S. The communication, dated november 2015, was entitled higher occurrence of irregular curves with factor viii chromogenic assay lot #44637. It instructed customers who had ordered the impacted lot of factor viii chromogenic assay on a sysmex ca-1500, ca-7000 in the u. S. And also, cs-2000i, cs-2100i, or cs5100 instruments outside the u. S. , to discontinue use of lot 44637. It notified customers that some patient results may show a positive bias of more than 20% over the complete measuring range and that results that cross the medical decision points might be incorrectly assessed. Further, the letter stated that due to a different detection principle, the use on bcs and bcs xp instruments is not affected and that they can continue using the product on bcs / bcs xp. Siemens healthcare diagnostics is continuing to investigate the issue. Siemens will provide an update to this report if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[31802037]
The customer complained of obtaining "no linearity" error flags with plasma n control with the factor viii (f viii) reagent lot 44637 on the cs-2000i instrument system. Patient samples were not impacted. No discrepant patient results were reported to physicians. Patient treatment was not altered or prescribed on the basis of the flagged plasma n control results with the f viii reagent. There was no report of adverse health consequences as a result of the flagged plasma n control results with the f viii reagent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2015-00073 |
| MDR Report Key | 5242302 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-11-23 |
| Date of Report | 2015-11-03 |
| Date of Event | 2015-04-13 |
| Date Mfgr Received | 2015-11-03 |
| Device Manufacturer Date | 2015-01-23 |
| Date Added to Maude | 2015-11-23 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | 76 EMIL VON BEHRING STRASSE |
| Manufacturer City | MARBURG, 35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 35041 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-11-18-2015-008-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FACTOR VIII CHROMOGENIC ASSAY |
| Generic Name | FACTOR VIII CHROMOGENIC ASSAY |
| Product Code | GGP |
| Date Received | 2015-11-23 |
| Catalog Number | B4238-40 |
| Lot Number | 44637 |
| Device Expiration Date | 2016-11-30 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 76 EMIL VON BEHRING STRASSE MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-23 |