MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-15 for IMMULITE 1000 30006 manufactured by Siemens Healthcare Diagnostics Inc..
[5256341]
The customer has obtained falsely low results on two patient samples for estradiol on an immulite 1000 instrument. Patient sample 1 was run neat and at a 1:5 dilution twice. Patient sample 2 was run neat and at a 1:2 dilution twice. In both instances the first result obtained on patient sample 1 at the 1:5 and the first result obtained on patient sample 2 at the 1:2 dilution were falsely low. The diluent lots used for the initial falsely low diluted result was different than the diluent lot used for the repeat result on both the patients samples. The neat and the diluted results were not reported to the physician(s), there are no known reports of patient intervention or adverse health consequences due to the falsely low estradiol results.
Patient Sequence No: 1, Text Type: D, B5
[12739881]
The customer obtained falsely low results on two diluted patient samples for estradiol on an immulite 1000 instrument. Due to the results obtained the customer used a new lot of diluent, rediluted the patient samples and the values obtained on the immulite 1000 were acceptable by the customer. The cause of the falsely low estradiol results on the two patient samples is unknown. 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 | 2247117-2014-00088 |
| MDR Report Key | 4330498 |
| Report Source | 05,06 |
| Date Received | 2014-12-15 |
| Date of Report | 2014-11-17 |
| Date of Event | 2014-11-15 |
| Date Mfgr Received | 2014-11-17 |
| Date Added to Maude | 2014-12-29 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 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 1000 |
| Generic Name | IMMULITE 1000 |
| Product Code | JJQ |
| Date Received | 2014-12-15 |
| Model Number | IMMULITE 1000 |
| Catalog Number | 30006 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY ROAD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-15 |