MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2017-12-14 for IMMULITE 2000/IMMULITE 2000 XPI OM-MA L2KOP manufactured by Siemens Healthcare Diagnostics Products, Limited.
[95617520]
Siemens healthcare diagnostics has confirmed that biotin interferes with the ca-125 (om-ma) assay on the immulite 2000/immulite 2000 xpi platform. At biotin concentrations of >5 ng/ml a positive bias that exceeds 10% has been observed on immulite 2000/immulite 2000 xpi platforms. This issue affects previously manufactured, in-date, and future lots. The immulite platform instructions for use (ifu's) currently do not have biotin listed as a potential interferent. An urgent field safety notice (ufsn) imc 18-02. A. Ous was sent out to ous customers and an urgent medical device recall (umdr) imc18-02. A. Us was sent to u. S customers on december 13, 2017. The ufsn and umdr informs the customers of biotin interference on all affected immulite assays. Siemens will update all ifu's with the appropriate biotin information.
Patient Sequence No: 1, Text Type: N, H10
[95617521]
Siemens technical operations internal investigation has identified that discordant falsely high results were obtained on two investigational samples on an immulite 2000/ immulite 2000 xpi instrument when using the om-ma (ca 125) assay. Two investigational samples were spiked with biotin at multiple concentrations, and run for investigational purposes on an immulite 2000/immulite 2000 xpi instrument. The results of the two samples spiked with 75 ng/ml and 250 ng/ml of biotin were falsely high with a bias of +41% and +38% 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 | 2432235-2017-00645 |
| MDR Report Key | 7118353 |
| Report Source | FOREIGN,STUDY |
| Date Received | 2017-12-14 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-12-01 |
| Date Mfgr Received | 2017-12-18 |
| Date Added to Maude | 2017-12-14 |
| 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 | UK REGISTRATION #: 3002806944 GLYN RHONWY |
| Manufacturer City | LLANBERIS, GWYNEDD LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-12/19/2017-004-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000/IMMULITE 2000 XPI OM-MA |
| Generic Name | IMMULITE 2000/IMMULITE 2000 XPI OM-MA |
| Product Code | LTK |
| Date Received | 2017-12-14 |
| Model Number | IMMULITE 2000/IMMULITE 2000 XPI OM-MA |
| Catalog Number | L2KOP |
| Lot Number | 290 |
| 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 | 2017-12-14 |