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 2017-01-31 for IMMULITE 2000 PROGESTERONE L2KPW manufactured by Siemens Healthcare Diagnostics Products, Limited.
[66154706]
A siemens technical application specialist (tas) was dispatched to the customer site. The tas ran sample id (b)(6) on the immulite 2000 xpi instrument and on the advia centaur instrument with and without human anti-mouse antibody (hama) blocking tube, and all results were lower indicating no hama interference. A siemens headquarters support center (hsc) specialist reviewed the sample data. The hsc specialist indicated that the immulite 2000 progesterone assay is traceable to an internal standard manufactured using qualified materials and measurement procedures. Progesterone methods vary in standardization across vendor platforms. No sample was available for in-house testing. The cause of the discordant, falsely low progesterone results on one patient is unknown. The device is performing within specification. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[66154707]
The customer obtained a discordant, falsely low progesterone result on one patient sample on an immulite 2000 xpi instrument, while using kit lot 466. The discordant result was reported to the physician(s), who questioned it. The sample was sent to an alternate laboratory where it was tested on an alternate platform, resulting higher and matching the clinical picture of the patient. The corrected result obtained from the alternate platform was reported to the physician(s). The sample was repeated on the immulite 2000 xpi instrument, still resulting lower. The sample was then repeated on the advia centaur instrument, resulting higher. The customer also reported that the previous sample (sample id (b)(6)) from this patient was also falsely low, when run on the immulite 2000 xpi instrument, while the result was higher when run on the alternate platform. It is unknown which result was reported for sample id (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00082 |
| MDR Report Key | 6289586 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-31 |
| Date of Report | 2017-01-31 |
| Date of Event | 2017-01-10 |
| Date Mfgr Received | 2017-01-11 |
| Date Added to Maude | 2017-01-31 |
| 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 | 2017-01-31 |
| Model Number | IMMULITE 2000 PROGESTERONE |
| Catalog Number | L2KPW |
| Lot Number | 466 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Address | REGISTRATION #: 3002806944 GLYN RHONWY LLANBERIS, GWYNEDD, LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-31 |