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.
[120834034]
The customer contacted a siemens customer care center (ccc) and reported that 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. Siemens is investigating the issue. 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 and mdr 9610806-2018-00098 were filed for discordant results obtained on samples from the same patient on (b)(6) 2018 and (b)(6) 2018, for the same issue.
Patient Sequence No: 1, Text Type: N, H10
[120834035]
Discordant, falsely elevated coagulation factor ix (factor ix) results were obtained on a patient sample on a bcs xp instrument, using the coagulation factor ix deficient plasma reagent. The sample was repeated using a non-siemens methodology, resulting lower. On (b)(6) 2017, the sample was repeated using the initial reagent lot, resulting in discordant, falsely elevated factor ix results. The patient blood was redrawn and the new sample was run multiple times, using the same reagent lot on (b)(6) 2017 and (b)(6) 2017, resulting in other discordant, falsely elevated factor ix results. The redrawn sample was also repeated using a non-siemens methodology, resulting lower. The customer indicated that some of the results determined by the coagulation factor ix deficient plasma reagent were reported to the physician(s), who questioned the results. The customer also stated that correct results were reported to the physician(s). 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 | 9610806-2018-00094 |
| MDR Report Key | 7890957 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-19 |
| Date of Report | 2018-11-09 |
| Date of Event | 2017-10-18 |
| 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 | 504122B |
| Device Expiration Date | 2018-10-12 |
| 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 |