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 2017-04-04 for IMMULITE 2000 BR-MA L2KBR2 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[71711755]
The cause of the falsely elevated ca 15-3 results with kit lot 262 is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[71711756]
The customer obtained falsely elevated ca 15-3 results on an immulite 2000 xpi instrument, while using kit lot 262. The initial result was reported to physician(s), who questioned the result. Repeat testing performed with the same sample and a new sample from the patient. The repeat results were also falsely elevated on the immulite 2000 xpi assay. The new sample from the patient was tested on an alternate platform at a different laboratory and the result was acceptable. It is unknown if the repeat results were reported to physician(s). There are no known reports of patient intervention due to the falsely elevated ca 15-3 result. There are no known reports of a delay in administering treatment or medical intervention to the patient due to the falsely elevated ca 15-3 result.
Patient Sequence No: 1, Text Type: D, B5
[76643982]
The initial mdr 2432235-2017-00248 was filed on april 4th, 2017. Additional information (04/27/2017): a siemens headquarter support center (hsc) specialist reviewed the data provided by the customer and did not find any discrepancies with the assay adjustments and recoveries of quality control materials. The immulite 2000 br-ma (ca 15-3) instructions for use (ifu) states that 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 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 cause of the bias between the methods cannot be determined. There were no other reports of discordant results being obtained with lot 262. Based on the available information, immulite 2000 br-ma (ca 15-3) lot 262 is performing as intended. The cause of the falsely elevated ca 15-3 results with kit lot 262 on the immulite 2000 xpi instrument is unknown. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2017-00248 |
| MDR Report Key | 6457722 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-04 |
| Date of Report | 2017-05-18 |
| Date of Event | 2017-02-23 |
| Date Mfgr Received | 2017-04-27 |
| Date Added to Maude | 2017-04-04 |
| 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 | DEVYANI CHAUDHURI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242637 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Street | UK 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 | 2017-04-04 |
| Model Number | IMMULITE 2000 BR-MA |
| Catalog Number | L2KBR2 |
| Lot Number | 262 |
| Device Expiration Date | 2017-04-30 |
| 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, LIMITED |
| Manufacturer Address | GLYN RHONWY LLANBERIS, GWYNEDD LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-04 |