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 2017-03-03 for COAGULATION FACTOR VIII DEFICIENT PLASMA OTXW17 SMN 10446411 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[69017056]
The customer contacted the siemens customer care center questioning the higher results obtained on the bcs xp relative to other non-siemens systems. Siemens headquarters support center (hsc) representatives have evaluated the information provided. Hsc concluded that review of all available information gives no indication of a systemic issue with the bcs xp system, reagent material, or laboratory practices at the customer laboratory. Routine quality control as well as prior survey samples recover acceptably. An overall problem with the fviii % activity application with actin fsl on the bcs xp system can be excluded. Patient comparisons have been conducted and demonstrate acceptable comparison for fviii % activity between the alternate vendor methods (non-siemens). Recovery of the samples fviii % activity on an alternate instrument system with actin fsl reagent and factor viii deficient plasma also was consistent with the bcs xp system recovery. Additionally, comparison across various lots of actin fsl compare well. Comparison of multiple external quality assessment survey vendor samples do not demonstrate a systemic bias. A clear difference in recovery with this specific sample is demonstrated between the application of siemens fviii with actin fsl on the bcsp xp as compared to competitors systems. The patient had received helixate fs product (recombinant factor viii concentrate) prior to collection of this sample. The recovery with siemens products is believed to be accurate for the sample provided to the laboratory for analysis. A false low bias is believed to be demonstrated with the alternate vendor products. The customer has confirmed that no irreparable harm was caused to the patient based upon the original value reported. The device is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[69017057]
A factor viii (fviii) result on a patient sample was questioned as discordant relative to values obtained with alternate reagent methodologies. The sample was tested with coagulation factor viii deficient plasma using the dade actin fsl reagent on the bcs xp instrument. The same sample was sent to alternate laboratories for testing. Lower results were obtained with two alternate non-siemens methodologies on non-siemens instruments. The physician questioned the initial fviii results with the siemens system as discordant with the clinical presentation. Patient did receive fviii concentrate four hours before the testing for fviii was performed. There is no indication that patient treatment was altered or prescribed on the basis of the questioned as discordant fviii result. There was no report of adverse health consequences as a result of the questioned as discordant fviii result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00028 |
| MDR Report Key | 6376100 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-03 |
| Date of Report | 2017-03-03 |
| Date of Event | 2017-02-02 |
| Date Mfgr Received | 2017-02-02 |
| Device Manufacturer Date | 2016-06-06 |
| Date Added to Maude | 2017-03-03 |
| 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 | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE 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 | EMIL VON BEHRING STRASSE 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 | COAGULATION FACTOR VIII DEFICIENT PLASMA |
| Generic Name | COAGULATION FACTOR VIII DEFICIENT PLASMA |
| Product Code | GJT |
| Date Received | 2017-03-03 |
| Catalog Number | OTXW17 SMN 10446411 |
| Lot Number | 547633 |
| Device Expiration Date | 2018-05-18 |
| 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, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-03 |