MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-28 for IMMULITE 2000 ERYTHROPOIETIN manufactured by Siemens Healthcare Diagnostics.
[3054339]
A discordant, falsely elevated erythropoietin (epo) result was obtained on a patient sample on the immulite 2000 instrument with lot # 230. The initial result was not reported to the physician. The sample was rerun to obtain the corrected result. There were no reports of patient intervention or adverse health consequences due to the discordant, falsely elevated epo result.
Patient Sequence No: 1, Text Type: D, B5
[10032189]
The customer called the technical solutions center (tsc) about the discordant epo result. The customer stated that the laboratory runs other assays (such as vitamin b12 and folate) that use the dilution well and that there are no problems with those assays. Based on this, the tsc specialist determined that the instrument did not require a field service engineer to inspect. The instructions for use (ifu) for the epo assay on the immulite 2000 instrument does indicate that the assay has limitations. The ifu states: "heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with in vitro immunoassays. " the cause of the discordant epo result is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00261 |
| MDR Report Key | 2716385 |
| Report Source | 05,06 |
| Date Received | 2012-08-28 |
| Date of Report | 2012-07-30 |
| Date of Event | 2012-07-30 |
| Date Mfgr Received | 2012-07-30 |
| Date Added to Maude | 2012-12-12 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MINDY LOSAPIO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242312 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | GLYN RHONWY LLANBERIS, CAERNARFON |
| Manufacturer City | GWYNEDD, WALES 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 ERYTHROPOIETIN |
| Generic Name | ERYTHROPOIETIN ASSAY |
| Product Code | GGT |
| Date Received | 2012-08-28 |
| Model Number | IMMULITE 2000 |
| Lot Number | 230 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | GLYN RHONWY LLANBERIS, CAERNARFON GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-28 |