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 2019-02-12 for N LATEX FLC LAMBDA 10482438 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[139066784]
The customer contacted a siemens customer care center and reported that a discordant free light chains (flc), type lambda (flc lambda) result was obtained on a patient sample on a bn prospec system. The customer previously contacted siemens regarding discordant flc lambda results obtained for this patient and mdrs 9610806-2019-00006 and 9610806-2019-00007 were filed for the discordant results previously obtained on the other samples from this patient. Siemens previously determined that there was no indication of a system malfunction and that the cause of the discordant flc lambda results was sample specific, but the customer did not have the sample for further investigation. The customer provided the affected sample for further investigation; siemens further investigated the issue and a study was performed on the affected sample. The sample was tested for flc lambda on a bn prospec system using the same reagent, and the flc lambda result confirmed the elevated recovery observed by the customer. Analysis of the sample portrayed that the flc lambda determinations were correctly evaluated by the bn prospec system; flc lambda concentration was present in a large protein complex in the sample. The system is performing according to specifications. No further evaluation of this device is required. Mdr 9610806-2019-00009 was filed for the elevated flc lambda result obtained on the week of 28-jan-2019 on another sample from the patient. Supplemental mdrs 9610806-2019-00006_s2 and 9610806-2019-00007_s2 were filed for the same issue.
Patient Sequence No: 1, Text Type: N, H10
[139066785]
A discordant, falsely elevated free light chains (flc), type lambda (flc lambda) result was obtained on a patient sample on a bn prospec system. The discordant result was not reported to the physician(s). The sample was also tested for flc lambda using a non-siemens method and the customer reported that a negative flc lambda result was obtained using the non-siemens method. The customer reported the negative flc lambda result to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated flc lambda result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2019-00008 |
| MDR Report Key | 8331431 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-02-12 |
| Date of Report | 2019-07-17 |
| Date of Event | 2019-01-14 |
| Date Mfgr Received | 2019-06-21 |
| Date Added to Maude | 2019-02-12 |
| 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 | 2019-02-12 |
| Model Number | N LATEX FLC LAMBDA |
| Catalog Number | 10482438 |
| Lot Number | 473242 |
| Device Expiration Date | 2019-05-15 |
| 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 | 2019-02-12 |