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 2019-01-11 for N LATEX FLC LAMBDA 10482438 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[134494609]
The customer contacted a siemens customer care center and reported that discordant, falsely elevated free light chains (flc), type lambda (flc lambda) results were obtained on a patient sample on the bn prospec system. A siemens customer service engineer (cse) was dispatched to the customer's site and collected system files. Siemens reviewed the reaction kinetics for the affected results and found no issue; the reaction kinetics correlated to the results obtained on the sample. Siemens determined that the sample was diluted by the system (in a 1:20 dilution, 1:100 dilution, 1:400 dilution, and 1:2000 dilution) until numerical results were obtained; numerical results were obtained on the sample after the 1:2000 dilution. There was no indication of a system malfunction, and siemens determined that the cause of the discordant flc lambda results was sample specific; the n latex flc lambda instructions for use (ifu) indicates that: "patient samples may contain heterophilic antibodies that could react in immunoassays to give a falsely elevated or depressed result. This assay has been designed to minimize interference from heterophilic antibodies. " the system is performing according to specifications. No further evaluation of this device is required. Mdr 9610806-2019-00006 was filed for the discordant flc lambda result obtained on (b)(6) 2018 and mdr 9610806-2019-00007 was filed for the discordant flc lambda result obtained on (b)(6) 2018.
Patient Sequence No: 1, Text Type: N, H10
[134494610]
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 reported to the physician(s), who questioned the result. The sample was also tested for flc lambda using a non-siemens method, and a lower result was obtained on the sample. On (b)(6) 2018, the sample was repeated on the same system, resulting in another discordant, falsely elevated flc lambda result. The discordant results were not corrected. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated flc lambda results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2019-00007 |
| MDR Report Key | 8239685 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-01-11 |
| Date of Report | 2019-07-17 |
| Date of Event | 2018-12-14 |
| Date Mfgr Received | 2019-06-21 |
| Date Added to Maude | 2019-01-11 |
| 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 | 2019-01-11 |
| 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 | 2019-01-11 |