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 2014-04-17 for IMMULITE 2000 XPI ANDROSTENEDIONE L2KAO manufactured by Siemens Healthcare Diagnostics Inc..
[4465942]
The customer has observed high results on three patient samples for the androstenedione assay on an immulite 2000 instrument. The patient sample values do not fit the clinical picture of the patient, as the other biomarkers tested on an alternate platform are within normal range. 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
[11720817]
Siemens has investigated the incidence of over recovery of patient samples and quality controls on the immulite/immulite1000 androstenedione assay lot number 409 and above, and immulite 2000/immulite 2000 xpi androstenedione assay lot number 314 and above. Siemens has confirmed that these lots are linear up to a concentration of 5. 5 ng/ml, instead of the 10 ng/ml as stated in the instructions for use (ifu). Quality control materials at concentrations between 5. 5 ng/ml and 10 ng/ml will detect this issue. An urgent medical device correction (umdc) 2013-12-19 was sent to us customers and an urgent field safety notice (ufsn) 4008 was sent to ous customers in december of 2013. The umdc and ufsn state that customers are requested to use quality control materials with at least two levels having concentrations less than 5. 5 ng/ml, and that patient values >5. 5 ng/ml should be verified using an alternate method.
Patient Sequence No: 1, Text Type: N, H10
[32142037]
The original mdr 2432235-2014-00286 was filed on april 17, 2014. Additional information (5/27/14): 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
[35335752]
The initial mdr 2432235-2014-00286 was filed on april 17, 2014. The first follow up mdr 2432235-2014-00286_s1 was filed on june 11, 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. An urgent field safety notice (ufsn) (b)(4) for immulite/immulite 1000 and ufsn (b)(4) 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 | 2432235-2014-00286 |
| MDR Report Key | 3756387 |
| Report Source | 01,05,06 |
| Date Received | 2014-04-17 |
| Date of Report | 2014-03-26 |
| Date of Event | 2014-03-26 |
| Date Mfgr Received | 2014-11-14 |
| Date Added to Maude | 2014-06-09 |
| 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 XPI ANDROSTENEDIONE |
| Generic Name | IMMULITE 2000 XPI ANDROSTENEDIONE |
| Product Code | CIZ |
| Date Received | 2014-04-17 |
| Model Number | IMMULITE 2000 XPI ANDROSTENEDIONE |
| Catalog Number | L2KAO |
| Lot Number | NOT PROVIDED |
| 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 | 2014-04-17 |