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 2019-01-11 for IMMULITE 2000 FREE PSA L2KPF2 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[133549022]
Assay adjustment (calibration) and quality control data from the customer has been provided for investigation. The cause of the discordant, falsely elevated results with the immulite 2000 free psa assay is unknown. Siemens is investigating the issue. Mdr 2432235-2019-0035 was filed for the same issue.
Patient Sequence No: 1, Text Type: N, H10
[133549023]
Discordant, falsely elevated results were obtained with two reagent lots of the immulite 2000 free psa assay on an immulite 2000 xpi instrument. The discordant results were reported to the physician(s) and were questioned. The same samples were repeated on an alternate platform from roche diagnostics. The results from the alternate platform were lower and considered to be correct. Corrected reports were issued to the physician(s) with the results from the roche diagnostics device. There are no known reports of any impact to patient treatment or intervention due to the discordant, falsely elevated free psa results. There are no known reports of a delay in administering treatment or medical intervention to the patients due to the discordant, falsely elevated free psa results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2019-00036 |
| MDR Report Key | 8240571 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-01-11 |
| Date of Report | 2019-03-21 |
| Date of Event | 2018-12-11 |
| Date Mfgr Received | 2019-03-01 |
| Date Added to Maude | 2019-01-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 FREE PSA |
| Generic Name | IMMULITE 2000 FREE PSA |
| Product Code | MTG |
| Date Received | 2019-01-11 |
| Model Number | IMMULITE 2000 FREE PSA |
| Catalog Number | L2KPF2 |
| Lot Number | 311 |
| 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 | 2019-01-11 |