MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-27 for N LATEX FLC LAMBDA 10482438 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[115525195]
Siemens is investigating the issue. Mdr 9610806-2018-00077 was filed for the discordant result obtained on the patient sample on the bn ii system in the middle of (b)(6). 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
[115525196]
A discordant, falsely low free light chains (flc), type lambda (flc lambda) result was obtained on a patient sample on a bn ii system. The discordant result was reported to the physician(s), who questioned the result. At the end of (b)(6) 2018, different samples from the patient were tested for flc lambda in two alternate laboratories, resulting higher than the initial result. The results obtained at the other laboratories were reported to the physician(s) and the highest result was considered to be the correct result. On (b)(6) 2018, the sample was diluted in a 1 to 10 dilution and repeated on the same bn ii system, resulting lower. The result obtained on the diluted sample was reported to the physician(s), who questioned the result. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low flc lambda results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00078 |
| MDR Report Key | 7726146 |
| Date Received | 2018-07-27 |
| Date of Report | 2018-08-28 |
| Date of Event | 2018-06-27 |
| 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 | 0 |
| 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 |