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 2016-10-14 for IMMULITE 2000 BR-MA L2KBR manufactured by Siemens Healthcare Diagnostics Products, Limited.
[57564353]
A siemens headquarters support center (hsc) specialist reviewed the data provided by the customer. The hsc specialist informed the customer that the immulite 2000 br-ma (cancer antigen 15-3) instructions for use (ifu) states the assay is for the quantitative measurement of br-ma in human serum, as an aid in the detection of recurrence in previously treated stage ii and stage iii breast cancer patients, and in the management of metastatic breast cancer patients by monitoring disease progression or response to treatment. It is not a screening assay. The expected values section of the ifu indicates there are small percentages of samples that will recover greater than 38 u/ml (normal females 5-6%, pregnant females 10%, and females without malignant disease 26%). As noted in the ifu, ca 15-3 antigen levels in a given specimen determined with assays from different manufacturers can vary due to differences in assay methods and reagent specificity. Results reported by the laboratory to the physician must include the identity of the assay used to measure ca 15-3 antigen levels. Values obtained with different assays cannot be used interchangeably. Before changing assays, the laboratory must confirm baseline values for patients being serially monitored. The immulite br-ma assay is a sandwich immunoassay that uses murine monoclonal antibodies to capture and detect ca 15-3 in serum. It is unknown which antibodies are used on the alternate platform. The cause of the discordant, falsely elevated br-ma results on one patient sample is unknown. The br-ma assay is performing as intended.
Patient Sequence No: 1, Text Type: N, H10
[57564354]
A discordant, falsely elevated br-ma (cancer antigen 15-3) result was obtained on one patient sample on an immulite 2000 xpi instrument while using kit lot 257. It is unknown if the discordant result was reported to the physician(s). The patient underwent image testing and there was no suspicion of any type of cancer. A new sample was obtained from the customer and was tested on the same instrument using kit lot 260 and the result was still elevated. The customer sent the sample to another laboratory where the sample was tested on an alternate platform. The result on the alternate platform was lower. The result obtained on the alternate platform was reported to the physician(s). There were no reports of adverse health consequences due to the discordant, falsely elevated br-ma results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00623 |
| MDR Report Key | 6029671 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-14 |
| Date of Report | 2016-10-14 |
| Date of Event | 2016-02-02 |
| Date Mfgr Received | 2016-09-20 |
| Date Added to Maude | 2016-10-14 |
| 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 | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Street | REGISTRATION #: 3002806944 GLYN RHONWY |
| Manufacturer City | LLANBERIS, GWYNEDD, LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 BR-MA |
| Generic Name | IMMULITE 2000 BR-MA |
| Product Code | MOI |
| Date Received | 2016-10-14 |
| Model Number | IMMULITE 2000 BR-MA |
| Catalog Number | L2KBR |
| Lot Number | 237/240 |
| 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, LIMITED |
| Manufacturer Address | REGISTRATION #: 3002806944 GLYN RHONWY LLANBERIS, GWYNEDD, LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-14 |