MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-12-03 for IMMULITE 2000 ANDROSTENEDIONE L2KAO manufactured by Siemens Healthcare Diagnostics Products Limited.
[18088723]
The customer has concerns regarding the dilution protocol for the androstenedione assay on the immulite 2000 instrument when using reagent lot 317. The customer is concerned with the linearity of the assay at <5. 5 ng/ml. There were no known reports of patient intervention or adverse health consequences due to the linearity concerns for the androstenedione assay.
Patient Sequence No: 1, Text Type: D, B5
[18464238]
Siemens has observed over-recovery in the immulite/immulite 1000/immulite 2000 androstenedione assay for samples across the assays' reportable range of 0. 3-10 ng/ml (1. 1-35 nmol/l). Siemens has confirmed that the issue noted in the december 2013 field action is not limited to only samples >5. 5 ng/ml (19. 2 nmol/l). Siemens has identified that the root cause of the over-recovery is related to the variability of a critical raw material. This issue has been resolved beginning with immulite/immulite 1000 kit lot 431, and for immulite 2000 beginning with kit lot 331. An urgent field safety notice (ufsn) 1113 for immulite/immulite 1000 and ufsn 3021 for immulite 2000 was sent to ous customers in november of 2014. The ufsn recommends that the customer discard the affected kit lots and to review the letter with their medical director.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2014-00679 |
| MDR Report Key | 4294818 |
| Report Source | 01,05,06 |
| Date Received | 2014-12-03 |
| Date of Report | 2014-11-14 |
| Date of Event | 2014-05-05 |
| Date Mfgr Received | 2014-11-14 |
| Date Added to Maude | 2014-12-12 |
| 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 | 0 |
| Manufacturer Contact | MS. ELIZABETH BEATO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243074 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED |
| Manufacturer Street | REGISTRATION # 3002806944 GLYN RHONWY |
| Manufacturer City | LLANBERIS, CAERNARFON, GWYNEDD, WALES LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-11/20/14-005R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 ANDROSTENEDIONE |
| Generic Name | IMMULITE 2000 ANDROSTENEDIONE |
| Product Code | CIZ |
| Date Received | 2014-12-03 |
| Model Number | IMMULITE 2000 ANDROSTENEDIONE |
| Catalog Number | L2KAO |
| Lot Number | 317 |
| Operator | OTHER HEALTH CARE 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, CAERNARFON, GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-03 |