MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-02 for IMMULITE 2000 PSA L2KPTS manufactured by .
[107318391]
Siemens customer care center (ccc) specialist offered to dispatch service to the customer site, but the customer declined. The customer informed siemens that there were no system performance errors or other errors related to reagents and components. The customer reviewed the results of 17 other patient samples that were run on the same instrument on (b)(6) 2018 and the results were acceptable. The customer could not confirm if the sample that was discordant was mixed well before being initially tested and the low result could have been due to sample handling issues. As there were no other errors identified on the system, the falsely low psa result may have been due to improper mixing of the sample. The system is performing within specifications.
Patient Sequence No: 1, Text Type: N, H10
[107318392]
A discordant, falsely low prostate specific antigen (psa) result was obtained on one patient sample on an immulite 2000 instrument. The discordant result was reported to the physician(s) and was questioned. The same sample was repeated on the same instrument, resulting higher. A new blood draw was taken from the same patient on a different date and was run on the day it was drawn on the same immulite 2000 instrument as the previous sample. The results of the repeat of the initial sample and the new blood draw matched. There are no known reports of patient intervention or adverse health consequences to the patient due to the discordant falsely low psa result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2018-00191 |
| MDR Report Key | 7481067 |
| Date Received | 2018-05-02 |
| Date of Report | 2018-05-02 |
| Date of Event | 2018-04-03 |
| Date Mfgr Received | 2018-04-10 |
| Date Added to Maude | 2018-05-02 |
| 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 | MARIE SYLVESTRE |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243172 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT, LIMITED |
| Manufacturer Street | REGISTRATION # 3002806944 GLYN RHONWY |
| Manufacturer City | LLANBERIS, GWYNEED LL55 4EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IMMULITE 2000 PSA |
| Generic Name | IMMULITE 2000 PSA |
| Product Code | MTF |
| Date Received | 2018-05-02 |
| Catalog Number | L2KPTS |
| Lot Number | D129 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-02 |