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 2013-10-28 for IMMULITE 2000 30002 manufactured by Siemens Healthcare Diagnostics Inc..
[3950076]
One patient sample tested for toxoplasma igm resulted positive on an immulite 2000 instrument. The result was reported to the laboratory information system (lis), which misinterpreted the result as negative. The discordant result was not reported to the physician(s) because the operator discovered the discrepancy before the result was reported. There are no reports of patient intervention or adverse health consequences due to the positive toxoplasma igm result being interpreted as negative by the lis.
Patient Sequence No: 1, Text Type: D, B5
[11445451]
A siemens application specialist was dispatched to the customer site. After evaluation of the instrument data, the application specialist did not find a malfunction with the immulite 2000 instrument. It was discovered that the lis was not configured to interpret the result of >10. The customer then reconfigured their lis host to interpret results that were transmitted from the immulite 2000 instrument. The cause of the positive toxoplasma igm result being misinterpreted by the lis as a negative result was a configuration issue. The immulite 2000 instrument performed according to specifications. This device is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2013-00109 |
| MDR Report Key | 3433653 |
| Report Source | 01,05,06 |
| Date Received | 2013-10-28 |
| Date of Report | 2013-10-03 |
| Date of Event | 2013-10-03 |
| Date Mfgr Received | 2013-10-03 |
| Date Added to Maude | 2014-01-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY RD |
| 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 |
| Generic Name | IMMULITE 2000 |
| Product Code | LJK |
| Date Received | 2013-10-28 |
| Model Number | IMMULITE 2000 |
| Catalog Number | 30002 |
| Operator | HEALTH 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 RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-28 |