MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-11-19 for IMMULITE 2000 030002 manufactured by Siemens Healthcare Diagnostics, Inc..
[17193131]
One (1) discordant high immulite 2000 ov result was obtained on one patient sample. The laboratory had been monitoring a patient (with a prior history of ovarian cancer) on a monthly basis. This patient had received chemotherapy which makes clotting unpredictable. After running the patient sample, the technicians ignored the delta check flag, which should have alerted them to repeat the sample. Patient received a biopsy, 2 radiographs and was set up for chemotherapy (which was not initiated). Repeat result the following month determined that the previous month's result was discordant.
Patient Sequence No: 1, Text Type: D, B5
[17236453]
The customer has refused a service visit as they feel that this is a sample specific issue. A siemens healthcare technical service engineer (tse) evaluated the instrument data (from (b)(4) 2010 only, instrument data files from (b)(4) 2010 and (b)(4) 2010 not available). Analysis of the instrument data indicate that there were no issues found in the file. It is thought that the root cause is due to user error because the technicians ignored the delta check, which should have alerted them to repeat the sample. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2010-00051 |
| MDR Report Key | 1909285 |
| Report Source | 05,06 |
| Date Received | 2010-11-19 |
| Date of Report | 2010-11-08 |
| Date of Event | 2010-10-12 |
| Date Mfgr Received | 2010-11-08 |
| Date Added to Maude | 2012-02-28 |
| 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 | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
| Manufacturer Street | 62 FLANDERS-BARTLEY RD. |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMUNO-ASSAY |
| Product Code | DGC |
| Date Received | 2010-11-19 |
| Model Number | NA |
| Catalog Number | 030002 |
| Lot Number | NA |
| 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, INC. |
| Manufacturer Address | FLANDERS NJ 07835 US 07835 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-19 |