MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-12-23 for IMMULITE 2000 30002 manufactured by Siemens Healthcare Diagnostics Inc..
[5203732]
The customer has obtained a false negative result on one patient sample for human chorionic gonadotropin (hcg) on an immulite 2000 instrument. The initial result on the patient sample was negative and as it did not fit the clinical picture of the patient, the sample was retested. The result obtained on the sample upon retesting was positive. The customer then ran the same sample five times on the same immulite 2000 instrument and the results were positive. The initial negative result was not reported to the physician(s). The repeated result on the patient sample was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to false negative hcg result.
Patient Sequence No: 1, Text Type: D, B5
[12622678]
A siemens field service engineer (fse) was dispatched to the customer site. The fse did not find any instrument related problems or errors. The customer informed the fse that they were using an expired reagent kit lot for hcg. The kit expired in september 2014 and the testing on the patient sample was carried out in december 2014. The cause of the false negative result on the patient sample 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 | 2247117-2014-00093 |
| MDR Report Key | 4357547 |
| Report Source | 01,05,06 |
| Date Received | 2014-12-23 |
| Date of Report | 2014-12-17 |
| Date of Event | 2014-12-12 |
| Date Mfgr Received | 2014-12-17 |
| Date Added to Maude | 2015-01-12 |
| 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 2000 |
| Generic Name | IMMULITE 2000 |
| Product Code | JJQ |
| Date Received | 2014-12-23 |
| Model Number | IMMULITE 2000 |
| Catalog Number | 30002 |
| 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 | 2014-12-23 |