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 2014-01-14 for IMMULITE 2000 ANDROSTENEDIONE L2KAO manufactured by Siemens Healthcare Diagnostics Inc..
[4144620]
The customer has observed high bias on biorad quality control sample level 2 for the androstenedione assay on an immulite 2000 instrument when using reagent lots 314 and 317. The customer has obtained values >10 ng/ml for biorad quality control sample level 2 when using reagent lot 314 and values of 8. 5 ng/ml when using reagent lot 317. The customer has not observed a positive bias on patient samples. There were no known reports of patient intervention or adverse health consequences due to the high bias observed on biorad quality control sample level 2 when using reagent lots 314 and 317.
Patient Sequence No: 1, Text Type: D, B5
[11560270]
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
[24991154]
The original mdr 2432235-2014-00129 was filed on january 14, 2014. Additional information (5/27/2014): 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
| Report Number | 2432235-2014-00129 |
| MDR Report Key | 3574968 |
| Report Source | 01,05,06 |
| Date Received | 2014-01-14 |
| Date of Report | 2013-12-18 |
| Date of Event | 2013-11-05 |
| Date Mfgr Received | 2014-05-27 |
| Date Added to Maude | 2014-04-16 |
| 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(REG#3002806944) |
| Manufacturer Street | GLYN RHOWNY LLANBERIS, CAERNARFON |
| Manufacturer City | GWYNEDD, WALES LL54EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL5 4EL |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-01/02/14-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 ANDROSTENEDIONE |
| Generic Name | IMMULITE 2000 ANDROSTENEDIONE |
| Product Code | CIZ |
| Date Received | 2014-01-14 |
| Model Number | IMMULITE 2000 ANDROSTENEDIONE |
| Catalog Number | L2KAO |
| Lot Number | 314, 317 |
| 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 | 2014-01-14 |