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 2014-07-14 for IMMULITE 2000 ANDROSTENEDIONE IMMULITE 2000 XPI ANDROSTENEDIONE L2KAO manufactured by Siemens Healthcare Diagnostics Inc..
[4603214]
The customer has observed high results on three patient samples for the androstenedione assay on an immulite 2000 instrument after performing a 1:4 dilution on the samples as per siemens protocol. The customer is concerned that patient samples that are less than 5. 5 ng/ml may be over recovering on the assay. The samples were sent out to be tested on an alternate platform where the results on the three patient samples were lower. The patient sample results were reported to the physician(s) who questioned the results. There were no known reports of patient intervention or adverse health consequences due to the high results observed on the patient samples for androstenedione.
Patient Sequence No: 1, Text Type: D, B5
[12133249]
The over recovery and loss of linearity of the immulite systems androstenedione assay has been identified to be variability of a critical raw material (variation in the activity of rma160 alkaline phosphatase (unlabeled/low activity alkaline phosphatase, cold ap) in the reagent wedge). In addition, siemens healthcare sent out a customer bulletin 2014-05 in may 2014, announcing the restoration of the linearity of the androstenedione assay on the immulite 2000/immulite 2000 xpi to 10 ng/ml (35 nml/l), beginning with kit lot 331.
Patient Sequence No: 1, Text Type: N, H10
[32286042]
The initial mdr 2432235-2014-00422 was filed on july 14, 2014. Additional information (11/14/14): 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2014-00422 |
| MDR Report Key | 3932872 |
| Report Source | 01,05,06 |
| Date Received | 2014-07-14 |
| Date of Report | 2014-06-23 |
| Date of Event | 2014-06-23 |
| Date Mfgr Received | 2014-11-14 |
| Date Added to Maude | 2014-07-24 |
| 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 RHOWNY |
| Manufacturer City | LLANBERIS, CAERNARFON, GWYNEDD, WALES LL54EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL5 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 | 2014-07-14 |
| Model Number | IMMULITE 2000 XPI ANDROSTENEDIONE |
| Catalog Number | L2KAO |
| Lot Number | 318 |
| Operator | OTHER HEALTH CARE 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 INC. |
| Manufacturer Address | GLYN RHONWY LLANBERIS, CAERNARFON, GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-14 |