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 2014-01-15 for IMMULITE 2000 ANDROSTENDIONE L2KA0 manufactured by Siemens Healthcare Diagnostics Inc..
[4073914]
The customer observed a positive bias and imprecision in the level 2 quality controls (qc) when using kit lot 317 of the immulite 2000 androstendione assay. The customer ran qc on an immulite 2000 instrument. The customer stated that they could not report patient results without two valid levels of qc. There are no known reports of adverse health consequences due to the positive bias in the immulite 2000 androstendione qc.
Patient Sequence No: 1, Text Type: D, B5
[11559848]
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) (b)(4) 2013 was sent to us customers and an urgent field safety notice (ufsn) (b)(4) 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
| Report Number | 2432235-2014-00047 |
| MDR Report Key | 3576069 |
| Report Source | 01,05,06 |
| Date Received | 2014-01-15 |
| Date of Report | 2013-12-18 |
| Date of Event | 2013-11-01 |
| Date Mfgr Received | 2013-12-18 |
| Date Added to Maude | 2014-04-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS (REG# 300280694) |
| Manufacturer Street | GLYN RHONWY LLANBERIS, CAERNARFON |
| Manufacturer City | GWENYDD, WALES LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 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 ANDROSTENDIONE |
| Generic Name | IMMULITE 2000 ANDROSTENDIONE |
| Product Code | CIZ |
| Date Received | 2014-01-15 |
| Model Number | IMMULITE 2000 ANDROSTENDIONE |
| Catalog Number | L2KA0 |
| Lot Number | 317 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | GLYN RHONWY CAERNARFON GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-15 |