MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-20 for IMMULITE 2000 ANDROSTENEDIONE L2KAO manufactured by Siemens Healthcare Diagnostics Products, Limited.
[63233172]
A siemens technical application specialist was dispatched to the customer site. The tas replaced the reagent pack and the issue resolved. The cause of the discordant, falsely elevated androstenedione results on multiple patient samples is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[63233173]
The customer obtained discordant, falsely elevated androstenedione results on multiple patient samples on an immulite 2000 xpi instrument, while using kit lot 349. The samples were repeated on the same instrument, resulting lower. The initial results were not reported to the physician(s). The repeat results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated androstenedione results.
Patient Sequence No: 1, Text Type: D, B5
[69122646]
The initial mdr 2432235-2016-00778 was filed on december 20, 2016. Additional information (02/01/2017): a siemens headquarters support center (hsc) specialist reviewed quality control and adjustment data and determined that they were unacceptable a day before the discordant results were obtained. The customer runs androstenedione assay two times a week and reagent packs are likely to remain on-board towards the end of the stability. The customer had 2 packs on-board (1 fresh and 1 unknown) at the time the discordant results were obtained. The hsc specialist stated that the reagent handling and/or storage may have caused the discordant results. The customer continues to process the patient samples and quality controls with no further issues. The cause of the discordant androstenedione results on multiple patient samples is unknown. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00778 |
| MDR Report Key | 6189519 |
| Date Received | 2016-12-20 |
| Date of Report | 2017-02-23 |
| Date of Event | 2016-11-17 |
| Date Mfgr Received | 2017-02-01 |
| Date Added to Maude | 2016-12-20 |
| 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 | 3 |
| Manufacturer Contact | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Street | UK REGISTRATION #: 3002806944 GLYN RHONWY |
| Manufacturer City | LLANBERIS, GWYNEDD LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 ANDROSTENEDIONE |
| Generic Name | IMMULITE 2000 ANDROSTENEDIONE |
| Product Code | CIZ |
| Date Received | 2016-12-20 |
| Model Number | IMMULITE 2000 ANDROSTENEDIONE |
| Catalog Number | L2KAO |
| Lot Number | 349 |
| Operator | HEALTH 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 PRODUCTS, LIMITED |
| Manufacturer Address | GLYN RHONWY LLANBERIS GWYNEDD, LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-20 |