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 2014-04-10 for IMMULITE 2000 XPI ANDROSTENEDIONE L2KAO manufactured by Siemens Healthcare Diagnostics Inc..
[4274080]
The customer has observed high bias on seven patient samples for the androstenedione assay on an immulite 2000 instrument. The patient sample values for androstenedione did not correspond clinically to values obtained on other hormonal markers. The results were reported to the physician(s) and questioned. There were no known reports of patient intervention or adverse health consequences due to the high bias observed on the patient samples.
Patient Sequence No: 1, Text Type: D, B5
[11908846]
The cause of the high bias observed on the patient samples for androstenedione is unknown. Siemens healthcare diagnostics is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[32993570]
The original mdr 2432235-2014-00277 was filed on april 10, 2014. Additional information (4/22/14): siemens global product support (gps) received information from the customer regarding the high values obtained on the seven patient samples for androstenedione on the immulite 2000 instrument. The customer informed gps that they are going to use the enhanced assay reference range values provided by siemens healthcare (customer bulletin (b)(4)) in october of 2011. Based on the enhanced assay reference range the seven patient samples stated in the mdr fell in the normal range of the assay. The customer has informed gps that no further assistance is needed. The system is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[37765779]
The initial mdr 2432235-2014-00277 was filed on (b)(6) 2014. The first follow up mdr 2432235-2014-00277_s1 was filed on (b)(6) 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) 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 | 2432235-2014-00277 |
| MDR Report Key | 3740816 |
| Report Source | 01,05,06 |
| Date Received | 2014-04-10 |
| Date of Report | 2014-03-17 |
| Date of Event | 2014-02-15 |
| Date Mfgr Received | 2014-11-14 |
| Date Added to Maude | 2014-06-03 |
| 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 | 2014-04-10 |
| 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 | 2014-04-10 |