MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-14 for IMMULITE 2000 30002 manufactured by Siemens Healthcare Diagnostics.
[3329506]
Discordant, non-linear dilution results for ca-125 antigen were obtained on two patient samples on an immulite 2000 instrument. The customer was performing a 1:10 and a 1:100 dilution on the patient samples, and the results were not linear relative to the neat results. Discordant results were not reported to the physician(s). There were no reports of patient intervention or adverse health consequences due to the discordant, non-linear results.
Patient Sequence No: 1, Text Type: D, B5
[10459398]
The cause of the non-linear dilution results on patient samples for ca-125 is unknown. Siemens is investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
[10730675]
The initial mdr 2247117-2013-00016 was filed on (b)(4) 2013 additional information ((b)(4) 2013): a siemens field service engineer (fse) was dispatched to the site to evaluate the instrument. The fse replaced the sample dual resolution dilutor (drd). The fse ran 1:10 and 1:100 dilutions in replicates of ten and then ran a system qc. All the data were within range. There were no further issues with ca 125 and all the results after the fse visit were acceptable to the customer. The instrument is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2013-00016 |
| MDR Report Key | 2961865 |
| Report Source | 05,06 |
| Date Received | 2013-02-14 |
| Date of Report | 2013-01-23 |
| Date of Event | 2013-01-23 |
| Date Mfgr Received | 2013-04-16 |
| Date Added to Maude | 2013-04-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. MICHAEL METZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242223 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | 62 FLANDERS BARTLEY ROAD |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMULITE 2000 |
| Product Code | DGC |
| Date Received | 2013-02-14 |
| Model Number | IMMULITE 2000 |
| Catalog Number | 30002 |
| Operator | OTHER HEALTH CARE 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 | 62 FLANDERS BARTLEY ROAD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-14 |