MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-04 for MULTIFIBREN U 10446691 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[142665867]
The customer contacted a siemens customer care center and reported that discordant, falsely elevated fibrinogen results were obtained on patient samples using multifibren u reagent on an atellica coag 360 system. Quality controls (qcs) were within acceptable ranges prior to and after the discordant results were obtained. The customer reported that the repeat results were obtained at another laboratory on a sysmex cs-5100 system using dade thrombin reagent. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[142665868]
Three discordant, falsely elevated fibrinogen results were obtained on three patient samples using multifibren u reagent on an atellica coag 360 system. The discordant results were reported to the physician(s). Two of the three samples were repeated using the fib multi u low method with the same multifibren u reagent on the same atellica coag 360 system, resulting lower. The same three samples were repeated at another laboratory on a sysmex cs-5100 system using dade thrombin reagent, also resulting lower. The customer did not indicate if the repeat 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 fibrinogen results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2019-00042 |
| MDR Report Key | 8482833 |
| Date Received | 2019-04-04 |
| Date of Report | 2019-06-06 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-05-14 |
| Date Added to Maude | 2019-04-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTOPHER AEBIG |
| Manufacturer Street | 511 BENEDICT AVE. |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242740 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS 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 | 0 |
| Brand Name | MULTIFIBREN U |
| Generic Name | MULTIFIBREN U |
| Product Code | KQJ |
| Date Received | 2019-04-04 |
| Model Number | MULTIFIBREN U |
| Catalog Number | 10446691 |
| Lot Number | 539041 |
| 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 PRODUCTS GMBH |
| Manufacturer Address | EMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-04 |