MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-16 for IMMULITE 2000 PROGESTERONE manufactured by Siemens Healthcare Diagnostics Products, Limited.
[50623627]
The cause of the discordant, falsely low progesterone results on one patient is unknown. Siemens healthcare diagnostics is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[50623628]
Discordant, falsely low immulite 2000 xpi progesterone results were obtained when comparing two samples drawn from the same patient within a few hours of one another. Sample id (b)(6) was initially tested on an alternate customer site and the results obtained on advia centaur xp and immulite 2000 xpi instruments did not match. One of the results obtained on advia centaur xp instrument was reported to the physician(s). A different sample was drawn from the patient a few hours later at this customer site. This sample was run on the immulite 2000 xpi and advia centaur xp instruments and the results still did not match. It is unknown which results were considered correct. There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low progesterone results.
Patient Sequence No: 1, Text Type: D, B5
[51355728]
The initial mdr 2432235-2016-00394 was filed on july 15, 2016. Additional information (07/25/2016): information regarding reagent lot # for immulite 2000 xpi progesterone was received. The reagent lot # is 457 and has been amended with this information. Additional information (07/28/2016): a siemens headquarters support center (hsc) specialist reviewed the data provided by the customer and indicated that different antibodies are used to create progesterone assay. Advia centaur xp uses mouse monoclonal and immulite 2000 xpi uses rabbit polyclonal antibodies, and therefore they can show different cross reactivity. The patient samples, medications or treatment were not provided for further investigation or to rule out cross reactivity. Immunoassays can be subject to a number of interferences including exogenous interferences such as drugs, nutritional supplements and/or herbal medicine in the blood. The hsc specialist reviewed the quality control data and indicated that the quality controls were acceptable indicating that the assay is performing as expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00394 |
| MDR Report Key | 5800078 |
| Date Received | 2016-07-16 |
| Date of Report | 2016-08-05 |
| Date of Event | 2016-06-19 |
| Date Mfgr Received | 2016-07-25 |
| Date Added to Maude | 2016-07-16 |
| 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 | 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 | 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 PROGESTERONE |
| Generic Name | IMMULITE 2000 PROGESTERONE |
| Product Code | JLS |
| Date Received | 2016-07-16 |
| Model Number | IMMULITE 2000 PROGESTERONE |
| Lot Number | 457 |
| 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 | 2016-07-16 |