MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-03-02 for IMMULITE 2000 ANDROSTENEDIONE L2KAO manufactured by Siemens Healthcare Diagnostics Products, Limited.
[68971816]
The customer facility was provided with androstenedione kit lot 354, which does not exhibit this issue. The cause of the falsely elevated androstenedione results with kit lot 353 is unkown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[68971817]
The customer observed a high bias with androstenedione results on an immulite 2000 xpi instrument, while using kit lot 353. The high bias caused the quality control materials to recover high out range, or at times, within range. When the quality control materials recovered high out of range, patient samples were not tested. When the quality control materials recovered within range, patient samples were tested and reported out. There was a delay in reporting out patient results when the quality control materials were out of range. It is unknown if there was any patient intervention or adverse health consequences due to the falsely elevated androstenedione results.
Patient Sequence No: 1, Text Type: D, B5
[73817909]
The initial mdr 2432235-2017-00158 was filed on march 2nd, 2017. Additional information (04/10/2017): the siemens technical support laboratory (tsl) evaluated androstenedione reagent kit lots 353, 354 and 355 and did not confirm a product issue with kit lot 353. The tsl did not confirm the observation of high out of range recoveries of quality control materials or high results with patient samples. The customer is running quality control materials and patient samples on the immulite 2000 xpi androstenedione assay without any further issues. Based on the available information, immulite 2000 xpi androstenedione lot 353 is performing as intended. The cause of the discordant androstenedione results is unknown. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2017-00158 |
| MDR Report Key | 6372531 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-02 |
| Date of Report | 2017-04-11 |
| Date of Event | 2017-02-13 |
| Date Mfgr Received | 2017-04-10 |
| Date Added to Maude | 2017-03-02 |
| 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 | DEVYANI CHAUDHURI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242637 |
| 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 | 2017-03-02 |
| Model Number | IMMULITE 2000 ANDROSTENEDIONE |
| Catalog Number | L2KAO |
| Lot Number | 353 |
| Device Expiration Date | 2017-07-31 |
| 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 | 2017-03-02 |