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 2018-09-19 for COAGULATION FACTOR IX DEFICIENT PLASMA manufactured by Siemens Healthcare Diagnostics Product Gmbh.
[120835211]
The customer contacted a siemens customer care center (ccc) and reported that a discordant, falsely elevated coagulation factor ix deficient plasma (fix),results were obtained on 4 samples from the same patient on the bcs xp system. There was no indication of a system malfunction and there were no reports of hardware errors when the discordant results were obtained on the patient samples. Quality controls were within expected ranges. Customer also ran non-siemens assays on the siemens bcs xp system, resulting in user defined method of testing. Siemens is investigating the issue. Mdr 9610806-2018-00094, mdr 9610806-2018-00095, and mdr 9610806-2018-00096 were filed for the discordant results obtained on (b)(6) 2017 and (b)(6) 2017 for the same issue. Mdr 9610806-2018-00097 was filed for discordant results obtained on (b)(6) 2018 for the same issue.
Patient Sequence No: 1, Text Type: N, H10
[120835212]
Discordant, falsely elevated coagulation factor ix (factor ix) results were obtained on a patient sample on a bcs xp system, using the coagulation factor ix deficient plasma reagent. The discordant result was not reported to the physician(s). The sample was repeated using a non-siemens method and on a bcs xp system, using the same coagulation factor ix deficient plasma reagent lot and a non-siemens reagent. The results obtained using the non-siemens reagent recovered lower than most results obtained using the siemens reagent. The sample was also sent to an alternate lab, where it was repeated using a non-siemens method, resulting lower. The lower results matched the clinical picture for the patient. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated factor ix results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00098 |
| MDR Report Key | 7890954 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-19 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-08-06 |
| Date Mfgr Received | 2018-10-24 |
| Date Added to Maude | 2018-09-19 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH |
| Manufacturer Street | EMIL-VON-BEHRING-STR. 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 IX DEFICIENT PLASMA |
| Generic Name | COAGULATION FACTOR IX DEFICIENT PLASMA |
| Product Code | GJT |
| Date Received | 2018-09-19 |
| Model Number | COAGULATION FACTOR IX DEFICIENT PLASMA |
| Lot Number | 504129B |
| Device Expiration Date | 2019-07-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH |
| Manufacturer Address | EMIL-VON-BEHRING-STR 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-19 |