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 2018-04-04 for BN PROSPEC SYSTEM 10465217 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[104738011]
The customer reported that the patient was monitored for kappa and lambda for some time using electrophoresis and the alternate non-siemens method; this was unknown by the customer when they reported the flc kappa and flc lambda results using siemens n latex flc lambda and n latex flc kappa reagents. The customer also indicated that they recently started using siemens reagents for determination of flc lambda and flc kappa and that the affected specimen is not available for further investigation. A siemens headquarters support center (hsc) specialist reviewed the data files on the bn prospec system to determine the cause of the event and found no issue. The hsc specialist determined that the save data files contained two quality control (qc) measurements and these results were within expected ranges. The hsc specialist also reviewed the kinetics of the affected measurement on 21-feb-2018 and qc and did not identify any issue. The kinetics of the sample measurement using the non-siemens method, which is not validated for use on the bn prospec system, were not in the data files provided by the customer. The hsc specialist concluded that there was no indication of a reagent or system malfunction. The cause of the event is unknown. The system and reagents are performing according to specifications. No further evaluation of these devices is required. Mdr 9610806-2018-00035, mdr 9610806-2018-00037, and mdr 9610806-2018-00038 were filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[104738012]
Discordant, falsely low free light chains (flc), type lambda (flc lambda) results were obtained on a patient sample on the bn prospec system using the n latex flc lambda reagent. These results were reported to the physician(s), who questioned the results as they did not match the patient's clinical history. The sample was also rerun on the same system using a higher dilution (to exclude a dose hook effect) and a result of <9. 94 mg/l was obtained. The sample was rerun on the same system, using a non-siemens method, resulting higher. The 3rd repeat result was reported as the expected result to the physician(s). Additionally, different free light chains (flc), type kappa (flc kappa) results were obtained on the same sample between the non-siemens method and the n latex flc kappa reagent on the same system. The 2nd repeat flc kappa measurement was run to exclude a high dose hook effect. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low flc lambda results and different flc kappa results obtained on the patient sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00036 |
| MDR Report Key | 7397596 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-04 |
| Date of Report | 2018-04-30 |
| Date of Event | 2018-02-21 |
| Date Mfgr Received | 2018-04-05 |
| Date Added to Maude | 2018-04-04 |
| 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 | 2018-04-04 |
| Model Number | BN PROSPEC SYSTEM |
| Catalog Number | 10465217 |
| 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 | 2018-04-04 |