MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-04 for IMMULITE 2000 XPI IMMULITE XPI 030001-03 manufactured by Siemens Healthcare Diagnostics Inc..
[25886998]
A siemens field service engineer (fse) visited the customer site. The fse carried out routine adjustments and alignments and also performed the monthly maintenance on the system. Quality control samples were then run on the system in multiple replicates and all values were within specifications. The cause of the falsely low results for gastrin 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
[25886999]
The customer has obtained a falsely low result on a patient sample for the gastrin assay on an immulite 2000 xpi instrument. The gastrin result on the sample was low compared to what the customer expected. The same sample was repeated on another immulite 2000 xpi instrument in the same laboratory and the result was higher (above analytical range). The customer diluted the sample 1:10 and the result obtained on the second immulite instrument was acceptable. The initial falsely low result was reported to the physician(s). The repeat result was not reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the falsely low gastrin result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2015-00048 |
| MDR Report Key | 5057454 |
| Date Received | 2015-09-04 |
| Date of Report | 2015-08-14 |
| Date of Event | 2015-08-03 |
| Date Mfgr Received | 2015-08-31 |
| Date Added to Maude | 2015-09-04 |
| 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 | 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 | 0 |
| Brand Name | IMMULITE 2000 XPI |
| Generic Name | IMMULITE 2000 XPI |
| Product Code | JJQ |
| Date Received | 2015-09-04 |
| 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 | 2015-09-04 |