MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2017-11-17 for IMMULITE/IMMULITE 1000 BR-MA LKBR1 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[93070783]
Siemens is evaluating the issue.
Patient Sequence No: 1, Text Type: N, H10
[93070784]
Siemens technical operations internal investigation has identified that discordant falsely low results were obtained on two investigational samples on an immulite/ immulite 1000 instrument when using the br-ma (ca15-3) assay. The two investigational samples were spiked with biotin at multiple concentrations and run for investigational purposes on an immulite/immulite 1000 instrument. The results of the two samples spiked with 500 ng/ml of biotin were falsely low with a bias of -71% and -51% respectively compared to results of the two samples without biotin. There were no patient samples impacted as this was for investigational purposes only.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00617 |
| MDR Report Key | 7041476 |
| Report Source | FOREIGN,STUDY |
| Date Received | 2017-11-17 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-10-26 |
| Date Mfgr Received | 2017-12-18 |
| Date Added to Maude | 2017-11-17 |
| 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 | UK REGISTRATION #: 3002806944 GLYN RHONWY |
| Manufacturer City | LLANBERIS, CAERNARFON, GWYNEDD LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-12/19/2017-004-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE/IMMULITE 1000 BR-MA |
| Generic Name | IMMULITE/IMMULITE 1000 BR-MA |
| Product Code | MOI |
| Date Received | 2017-11-17 |
| Model Number | IMMULITE/IMMULITE 1000 BR-MA |
| Catalog Number | LKBR1 |
| Lot Number | 313 |
| 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, CAERNARFON, GWYNEDD LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-17 |