MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-05-03 for IMMULITE 2000 TOXOPLASMA IGG N/A L2KTXP manufactured by Siemens Healthcare Diagnostics.
[1851064]
A discordant immulite 2000 false positive toxoplasma igg result was obtained on one (1) patient sample. (the patient had previously tested negative several months prior). The positive sample was then sent to a second laboratory for confirmation, the result returned was negative. There is no known report of patient intervention or adverse health consequences due to the discordant toxoplasma igg result.
Patient Sequence No: 1, Text Type: D, B5
[9029434]
A siemens technical service engineer (tse) evaluated the immulite 2000 instrument data. Analysis of the instrument data indicated that the cause for the discordant toxoplasma igg result is unknown. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[22129787]
Siemens filed the initial mdr 2432235-2011-00065 on (b)(4) 2011. 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 | 2432235-2011-00065 |
| MDR Report Key | 2074946 |
| Report Source | 05,06 |
| Date Received | 2011-05-03 |
| Date of Report | 2011-04-08 |
| Date of Event | 2011-02-14 |
| Date Mfgr Received | 2011-09-01 |
| Date Added to Maude | 2012-02-01 |
| 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 IGG IMMUNOASSAY |
| Product Code | DGC |
| Date Received | 2011-05-03 |
| Model Number | N/A |
| Catalog Number | L2KTXP |
| Lot Number | 362 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | LLANBERRIS GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-03 |