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 2017-01-03 for IMMULITE 2000 XPI manufactured by Siemens Healthcare Diagnostics Inc..
[63725792]
The cause of the false reactive results for toxoplasma igg is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[63725793]
The customer has obtained false reactive results on two patient samples for toxoplasma igg on an immulite 2000 xpi instrument. The initial result on both samples was reactive, and when repeated on the same instrument again the result was non-reactive, which was the expected result. The initial and repeat results were not reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the false reactive results on the immulite 2000 xpi instrument.
Patient Sequence No: 1, Text Type: D, B5
[65918655]
Initial mdr 2247117-2017-00001 was filed on 1/3/2017. Additional information (1/5/2017): a siemens field service engineer was dispatched to the customer site. The fse evaluated the instrument and confirmed that the system was performing as expected and was in proper condition. In addition a siemens headquarters support center (hsc) reviewed the instrument files provided by the customer. The files showed no indication of sample, reagent, and diluent level sense issues when the sample was run. Multiple "liquid waste full" errors were detected at the time the issue occurred. The cause of the falsely high result is unknown. The system is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2017-00001 |
| MDR Report Key | 6218263 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-03 |
| Date of Report | 2017-01-06 |
| Date of Event | 2016-11-22 |
| Date Mfgr Received | 2017-01-05 |
| Date Added to Maude | 2017-01-03 |
| 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 |
| 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 | 3 |
| Brand Name | IMMULITE 2000 XPI |
| Generic Name | IMMULITE 2000 XPI |
| Product Code | LGD |
| Date Received | 2017-01-03 |
| Model Number | IMMULITE 2000 XPI |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY ROAD FLANDERS NY 07836 US 07836 |
| Brand Name | IMMULITE 2000 XPI |
| Generic Name | IMMULITE 2000 XPI |
| Product Code | JJQ |
| Date Received | 2017-01-03 |
| Model Number | IMMULITE 2000 XPI |
| Device Availability | * |
| Device Age | DA |
| 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 NY 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-03 |