MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-02-05 for IMMULITE 2000 30002 manufactured by Siemens Healthcare Diagnostics Inc..
[18000695]
The customer has obtained a false negative result on one patient sample for human chorionic gonadotropin (hcg) on an immulite 2000 instrument. The false negative result was reported to the physician and was questioned as it did not align with the clinical picture of the patient. A new sample draw was obtained from the patient and retested it on the same immulite 2000 instrument and the result was positive. The sample was then diluted and tested again and the result was positive. The initial sample was then rerun on the same immulite 2000 instrument and the result was positive. This sample was also diluted and tested on the instrument and the result was positive. The results of the new sample draw and the repeat results of the initial sample were 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
[18316323]
A siemens field service engineer (fse) was dispatched to the customer site. The fse performed a system check and found that the substrate was overfilled and had thus overflowed into the scrubber which caused the co2 scrubber to become damaged. In addition the tubing connected to the scrubber was kinked. The fse ran a quality control check and samples recovered within specifications. The cause of the false negative hcg result 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 | 2247117-2015-00003 |
| MDR Report Key | 4487997 |
| Report Source | 05,06 |
| Date Received | 2015-02-05 |
| Date of Report | 2015-01-16 |
| Date of Event | 2015-01-08 |
| Date Mfgr Received | 2015-01-16 |
| Date Added to Maude | 2015-03-10 |
| 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 | 2015-02-05 |
| 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 | 2015-02-05 |