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 2018-02-13 for BN PROSPEC SYSTEM 10461865 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[100260166]
Siemens healthcare diagnostics (siemens) analyzed the kinetic curves to determine the cause of the discordant, falsely low results obtained on the patient sample on the bn prospec system and determined that turbidity, not due to the sample reaction, potentially contributed to the discordant results. This was potentially caused by insufficient centrifugation of the sample prior to running the sample. Upon further investigation, siemens determined that a sample specific or pre-analytical issue potentially contributed to the discordant results since discordant results were obtained for multiple assays on the affected sample. Siemens also determined that the operator centrifuged samples at a sufficient time and speed, but recommended that the operator increase their centrifuge time. Siemens provided a table with recommended sample storage time, for each assay, to the operator. On (b)(6) 2018, the operator informed siemens that they increased their centrifuge time and reported that they obtained imprecise a1-antitrypsin and immunoglobulin m (igm) results on riqas proficiency testing samples. The operator indicated that they were running patient samples and quality controls routinely and quality controls were recovering within expected ranges. A siemens headquarters support center (hsc) specialist analyzed the bn prospec system files to determine the cause of the imprecise a1-antitrypsin and igm results obtained on the riqas proficiency testing samples and found no issue. The hsc specialist indicated that the kinetic curves recovered as expected and that the bit values for these assays correlated to the concentration results. There were no errors in the error log files that potentially contributed to the imprecise results. The cause of the event is unknown. The system and reagents are performing according to specifications. No further evaluation of this system is required. The operator reported that two patient samples (sample id (b)(6)) were impacted by this event. Mdr 9610806-2018-00024 was filed for sample id (b)(6) and mdr 9610806-2018-00025 was filed for sample id (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[100260167]
Discordant, falsely low immunoglobulin g (igg), immunoglobulin a (iga), immunoglobulin m (igm), kappa, lambda, and beta 2- microglobulin results were obtained on a patient sample on the bn prospec system. These results were not reported to the physician(s). The same sample was rerun on the same system, resulting higher than the initial results. The repeat results were the correct results 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 igg, iga, igm, kappa, lambda, and beta 2- microglobulin results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00024 |
| MDR Report Key | 7266708 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-13 |
| Date of Report | 2018-03-20 |
| Date of Event | 2017-10-31 |
| Date Mfgr Received | 2018-02-23 |
| Date Added to Maude | 2018-02-13 |
| 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 | 2018-02-13 |
| Model Number | BN PROSPEC SYSTEM |
| Catalog Number | 10461865 |
| 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 | 2018-02-13 |