MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-03-27 for IMMULITE 2000 XPI IMMULITE XPI 030001-03 manufactured by Siemens Healthcare Diagnostics Inc..
[5617958]
The customer has obtained falsely low results on a patient sample for the prolactin assay on an immulite 2000 xpi instrument. The patient sample was run neat in duplicate. Both values were above the analytical range. The system then performed an auto dilution of the sample and the results were lower. The customer questioned the results as they had prior results on the sample which were higher. The customer re-ran a thawed sample from the same patient the next day, neat and diluted and the values were still not acceptable. The initial falsely low results on the diluted patient sample were not reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the falsely low prolactin results.
Patient Sequence No: 1, Text Type: D, B5
[13078258]
The customer has informed siemens healthcare diagnostics that they re-ran the samples with a new diluent and the results were acceptable, and did not need further support. The cause of the falsely low results for prolactin is unknown. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2015-00117 |
| MDR Report Key | 4638652 |
| Report Source | 01,05,06 |
| Date Received | 2015-03-27 |
| Date of Report | 2015-03-11 |
| Date of Event | 2015-03-08 |
| Date Mfgr Received | 2015-03-11 |
| Date Added to Maude | 2015-04-29 |
| 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 | 0 |
| 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 INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY ROAD |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 XPI |
| Generic Name | IMMULITE 2000 XPI |
| Product Code | JJQ |
| Date Received | 2015-03-27 |
| Model Number | IMMULITE XPI |
| Catalog Number | 030001-03 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY ROAD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-27 |