MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-11-12 for IMMULITE 2000 TOXOPLASMA IGG L2KTXP manufactured by Siemens Healthcare Diagnostics Inc.
[1675777]
False positive toxoplasma igg results were obtained on an immulite 2000 system for one (1) pt sample. The pt initially had a negative toxoplasma igg result and the following month the same pt tested positive. The sample was repeated several times and results were reproducible with 2 different lots of the same reagent. The same sample was tested on two other instruments which gave negative results. The negative results were reported to the physician. There was no report of pt intervention or adverse health consequences due to the discordant toxoplasma igg results.
Patient Sequence No: 1, Text Type: D, B5
[8976614]
A siemens field service engineer (fse) was sent to the customer site. Analysis of the immulite 2000 system indicate that there are no known system causes which may have contributed to the discordant positive toxoplasma igg results. The system is performing within specifications. No further eval of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[9848187]
Siemens filed the initial mdr 2432235-2010-00170 on (b)(6) 2010. Updated (b)(4) 2012: it was found that a lot of bovine serum albumin (bsa) was the cause of the false positive immulite systems toxoplasma quantitative igg results, however siemens has investigated the issue and has determined that the frequency of the false positive patient results reported are within the ifu specificity claims of (b)(4) for the immulite systems toxoplasma quantitative igg assay.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2010-00170 |
| MDR Report Key | 1902415 |
| Report Source | 05,06 |
| Date Received | 2010-11-12 |
| Date of Report | 2010-10-15 |
| Date of Event | 2010-10-12 |
| Date Mfgr Received | 2011-09-01 |
| Date Added to Maude | 2012-03-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BARBARA KVASNOSKY |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243658 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | GLYN RHONWY LLANBERIS |
| Manufacturer City | GWYNEDD, WALES LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 TOXOPLASMA IGG |
| Generic Name | TOXOPLASMA GONDII IMMUNOASSAY |
| Product Code | DGC |
| Date Received | 2010-11-12 |
| Model Number | NA |
| Catalog Number | L2KTXP |
| Lot Number | 360/361 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Address | LLANBERIS, GWYNEDD LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-12 |