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 2018-02-15 for BN PROSPEC SYSTEM 10465217 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[100443583]
A siemens healthcare diagnostics (siemens) headquarters support center (hsc) specialist analyzed the calibration data and the patient results to determine the cause of the discordant, falsely low results on multiple assays on the bn prospec system. The hsc specialist determined that all assays were calibrated and the calibration curves recovered as expected. Since the affected bn prospec system save data files were not provided for further evaluation, the cause of the event is unknown. The repeat results were obtained using the same reagent lots and system as the initial results. Due to this, the hsc specialist determined that the system and reagents are performing according to specifications. No further evaluation of this system is required.
Patient Sequence No: 1, Text Type: N, H10
[100443584]
Discordant, falsely low immunoglobulin g (igg), immunoglobulin a (iga), immunoglobulin m (igm), and bound and free lambda type of human immunoglobulin light chains (ig/l chain, type lambda) results were obtained on a patient serum sample on the bn prospec system. The sample was also tested for bound and free kappa type of human immunoglobulin light chains (ig/l chain, type kappa), resulting within expected ranges. All these results were reported to the physician, who questioned the discordant, falsely low results. The same sample was rerun for igg, ig/l chain, type lambda, and ig/l chain, type kappa on the same system. Other low discordant results were obtained for igg and ig/l chain, type lambda. Upon repeat, discordant, falsely low ig/l chain, type kappa results were obtained at 1:20 dilution on the patient sample. On (b)(6) 2018, the same patient sample was retested for all parameters, except ig/l chain, type kappa, on the same system, resulting higher than the initial results. These results were more plausible for this patient and were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low results obtained on the patient sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00026 |
| MDR Report Key | 7275386 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-15 |
| Date of Report | 2018-02-15 |
| Date of Event | 2018-01-11 |
| Date Mfgr Received | 2018-01-22 |
| Date Added to Maude | 2018-02-15 |
| 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 |
| 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 | BIT ANALYTICAL INSTRUMENTS GMBH |
| Manufacturer Street | AM KRONBERGER HANG 3 REGISTRATION NUMBER:3003601075 |
| Manufacturer City | SCHWALBACH, 65824 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65824 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BN PROSPEC SYSTEM |
| Generic Name | BN PROSPEC SYSTEM |
| Product Code | JZW |
| Date Received | 2018-02-15 |
| Model Number | BN PROSPEC SYSTEM |
| Catalog Number | 10465217 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-02-15 |