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 2019-04-03 for IMMULITE 2000 FREE PSA L2KPF2 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[147171640]
A siemens customer care center specialist (ccc) reviewed the calibration/adjustment data of immulite 2000 xpi free psa lot 313 from the customer. The adjustments and quality control (qc) data were valid and within expected ranges. A siemens technical application specialist (tas) communicated that the sample was no longer available. Further evaluation of the sample, including testing with heterophilic blocking tubes (hbt), could not be performed. A siemens headquarter support center specialist (hsc) reviewed the data collected by the customer, performed a search of the historic database on 25-mar-2019, and found no additional discordant falsely elevated results complaints for immulite 2000 xpi free psa lot 313. Hsc found that the possibility of interference from heterophilic and/ or non-specific binding antibodies, or sample specific issues could not be excluded. Based on the information provided, the falsely high free psa results are not due to a system or reagent lot issue. Unknown interference in the patient sample is suspected. Immulite 2000 xpi free psa kit lot 313 is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[147171641]
Discordant, falsely elevated free prostate-specific antigen (free psa) results were obtained using an immulite 2000 xpi instrument. The initial discordant result was not reported to the physician(s). The sample was repeated in dilution of 1:3, 1:5, and 1:10 of the neat sample. The sample resulted lower than the initial discordant result each time it was diluted. The repeat result obtained with 1:10 dilution was considered to be correct and reported to the physician(s). There are no known reports of patient intervention or adverse health consequences 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 | 2432235-2019-00118 |
| MDR Report Key | 8478225 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-04-03 |
| Date of Report | 2019-04-03 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-03-13 |
| Date Added to Maude | 2019-04-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MARDOCHEE TIMOLIEN |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242503 |
| 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 | 2019-04-03 |
| Model Number | IMMULITE 2000 FREE PSA |
| Catalog Number | L2KPF2 |
| Lot Number | 313 |
| Device Expiration Date | 2019-11-30 |
| 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 | GLYN RHONWY LLANBERIS, GWYNEDD LL554E UK LL55 4E |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-03 |