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 2018-07-27 for N LATEX FLC LAMBDA 10482438 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[115529232]
The exact date when the customer obtained the discordant, falsely low flc lambda result in (b)(6) of 2018 is unknown; date of event was left blank due to the unknown date. Siemens is investigating the issue. Mdr 9610806-2018-00078 was filed for the discordant result mentioned that was obtained on (b)(6) 2018. Mdr 9610806-2018-00079 was filed for the discordant result mentioned that was obtained on (b)(6) 2018.
Patient Sequence No: 1, Text Type: N, H10
[115529233]
The customer reported that they obtained a discordant, falsely low free light chains (flc), type lambda (flc lambda) result on a patient sample on a bn ii system in april of 2018. The customer reported that higher results were obtained on other samples from the patient at alternate laboratories. The customer did not provide further details nor the discordant result obtained in april. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low flc lambda result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00077 |
| MDR Report Key | 7726160 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-27 |
| Date of Report | 2018-08-28 |
| Date Mfgr Received | 2018-07-27 |
| Date Added to Maude | 2018-07-27 |
| 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 PRODUCTS GMBH |
| Manufacturer Street | EMIL-VON-BEHRING- STR. 76 REGISTRATION NUMBER:3003601075 |
| 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 | N LATEX FLC LAMBDA |
| Generic Name | N LATEX FLC LAMBDA |
| Product Code | DEH |
| Date Received | 2018-07-27 |
| Model Number | N LATEX FLC LAMBDA |
| Catalog Number | 10482438 |
| Lot Number | 473241 |
| Device Expiration Date | 2018-11-09 |
| 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 | 2018-07-27 |