MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-01-28 for IMMULITE 2000 N/A 030002 manufactured by Siemens Healthcare Diagnostics.
[1899883]
A discordant immulite 2000 toxoplasma igg result was obtained on one (1) patient sample. Initially a pregnant patient was tested for toxoplasma igg with a negative result. Two months later the same patient gave a positive result. The laboratory questioned the positive result and repeated the sample on three different systems to confirm, all of which were negative. Three days later another sample was tested from the same patient which also gave a positive result and negative results on the alternative systems. The corrected negative result was reported to the physician. There was no report of adverse health consequences due to the discordant toxoplasma igg result.
Patient Sequence No: 1, Text Type: D, B5
[8970397]
The customer refused assistance with any instrument review and the cause for the discordant toxoplasma igg result is unknown. The instrument is performing within specifications. No further evaluation of the device is required note: customer will not provide instrument serial number, only that it is an i series instrument.
Patient Sequence No: 1, Text Type: N, H10
[9849122]
Siemens filed the initial mdr 2432235-2011-00013 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
[20735167]
A discordant immulite 2000 toxoplasma igg result was obtained on one (1) patient sample. Initially, a pregnant patient was tested for toxoplasma igg with a negative result. Two months later, the same patient gave a positive result. The laboratory questioned the positive result and repeated the sample on three different systems to confirm, all of which were negative. Three days later, another sample was tested from the same patient which also gave a positive result and negative results on the alternative systems. The corrected negative result was reported to the physician. There was no report of adverse health consequences due to the discordant toxoplasma igg result.
Patient Sequence No: 1, Text Type: D, B5
[20905653]
The customer refused assistance with any instrument review and the cause for the discordant toxoplasma igg result is unknown. The instrument is performing within specifications. No further evaluation of the device is required. Note: customer will not provide instrument serial number, only that it is an i series instrument. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2011-00013 |
| MDR Report Key | 1972227 |
| Report Source | 05,06 |
| Date Received | 2011-01-28 |
| Date of Report | 2011-01-10 |
| Date of Event | 2010-12-01 |
| Date Mfgr Received | 2011-09-01 |
| Date Added to Maude | 2012-05-09 |
| 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 NJ 07836LL5 |
| Manufacturer Country | UK |
| Manufacturer Postal Code | 07836 LL55 |
| 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 | 2011-01-28 |
| Model Number | N/A |
| Catalog Number | 030002 |
| 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 |
| Manufacturer Address | FLANDERS NJ 07835 US 07835 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-28 |