MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-02-02 for IMMULITE 2000 6607666 manufactured by Siemens Healthcare Diagnostics Products Ltd..
[9862873]
Siemens filed the initial mdr 2432235-2011-00015 on (b)(4) 2011. Updated 05/09/2012: 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 99. 4% for the immulite systems toxoplasma quantitative igg assay.
Patient Sequence No: 1, Text Type: N, H10
[19202189]
Discordant high toxoplasma igg (txp) results were obtained on an immulite 2000 with five (5) of six (6) samples drawn from two (2) patients using txp reagent lot 361. The six patient samples were collected in october, november, and december of 2010. The october samples for each patient initially tested negative with another lot of txp reagent. An external lab confirmed that five (5) of the six (6 ) samples are negative for toxoplasma igg, igm and iga. The discordant results were not reported to the physician. Patient treatment was not altered or prescribed. There was no report of adverse health consequences due to the discordant toxoplasma igg results.
Patient Sequence No: 1, Text Type: D, B5
[19423059]
There are no known reports of system problems. The instrument is performing within specifications. No further evaluation of the device is required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2011-00015 |
| MDR Report Key | 1977202 |
| Report Source | 05,06 |
| Date Received | 2011-02-02 |
| Date of Report | 2011-01-07 |
| Date of Event | 2010-11-17 |
| Date Mfgr Received | 2011-09-01 |
| Date Added to Maude | 2012-02-06 |
| 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 |
| Generic Name | IMMUNO-ASSAY |
| Product Code | DGC |
| Date Received | 2011-02-02 |
| Model Number | IMMULITE 2000 |
| Catalog Number | 6607666 |
| Lot Number | 361 |
| ID Number | L2KTXP |
| Device Expiration Date | 2011-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD. |
| Manufacturer Address | GLYN RHONWY LLANBERIS, GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-02 |