MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-12-16 for IMMULITE 2000 TOXOPLASMA IGG L2KTXP manufactured by Siemens Healthcare Diagnostics Products, Ltd..
[1824787]
Discordant high toxoplasma igg results were obtained for samples from three (3) pts on immulite 2000. For pt #1, 2 fresh samples and an older sample (from (b)(6) 2010) were tested. One sample each was tested for pt #2 and pt #3. The samples were also tested in a second lab on another immulite 2000 system, using the same lot of reagent, and discordant high results were obtained again. The three samples were then tested on another system and the results were found to be negative. (the customer noted that the results from the add'l testing were negative, but did not provide specific pt data from the other immulite 2000, or the other system. ) the customer did not indicate which testing results were reported. Pt treatment was not altered or prescribed. There were no reports of adverse health consequences due to the discordant toxo igg results.
Patient Sequence No: 1, Text Type: D, B5
[8808616]
A siemens healthcare diagnostics field applications specialist (fas) visited the customer site. There are no known reported system issues.
Patient Sequence No: 1, Text Type: N, H10
[9862391]
Siemens filed the initial mdr 2432235-2010-00190 on (b)(4) 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 | 2432235-2010-00190 |
| MDR Report Key | 1937797 |
| Report Source | 05,06 |
| Date Received | 2010-12-16 |
| Date of Report | 2010-11-24 |
| Date of Event | 2010-11-24 |
| Date Mfgr Received | 2011-09-01 |
| Date Added to Maude | 2011-01-24 |
| 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 | 2010-12-16 |
| Model Number | NA |
| Catalog Number | L2KTXP |
| Lot Number | 360 |
| ID Number | NA |
| 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 PRODUCTS, LTD. |
| Manufacturer Address | LANBERIS, GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-16 |