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 THYROGLOBULIN LKTY1 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[93071030]
Siemens is evaluating the issue.
Patient Sequence No: 1, Text Type: N, H10
[93071031]
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 thyroglobulin (tg) 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 19 ng/ml of biotin were falsely low with a bias of -26% and -32% 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 | 2432235-2017-00618 |
MDR Report Key | 7041483 |
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, 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 THYROGLOBULIN |
Generic Name | IMMULITE/IMMULITE 1000 THYROGLOBULIN |
Product Code | MSW |
Date Received | 2017-11-17 |
Model Number | IMMULITE/IMMULITE 1000 THYROGLOBULIN |
Catalog Number | LKTY1 |
Lot Number | 290 |
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 | 2017-11-17 |