MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-03-01 for IMMULITE 2000 manufactured by Siemens Healthcare Diagnostics Inc..
[39444331]
A siemens headquarters support center (hsc) specialist reviewed the instrument data and did not find any instrument malfunction. Quality controls were acceptable on the day discordant results were obtained. The cause of the discordant folic acid results on patient samples is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[39444332]
Discordant folic acid serum versus whole blood folic acid results were obtained on three patient samples on an immulite 2000 instrument. Additionally, discordant folic acid serum results were obtained on three patient samples when run neat versus diluted. Samples for patients 1, 2 and 3 were run using a serum sample and the initial and repeat results were similar. Also, whole blood samples were run for folic acid, which resulted similar on initial and repeat runs except for patient 3, which resulted lower on repeat run. Whole blood folic acid results were different from the serum folic acid results for all three patient samples. Samples for patients 4, 5 and 6 were run neat initially. The samples were then repeated with different dilution factors and the results were different between various dilutions. It is unknown which results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant folic acid results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2016-00010 |
| MDR Report Key | 5471153 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-01 |
| Date of Report | 2016-02-05 |
| Date of Event | 2016-01-11 |
| Date Mfgr Received | 2016-02-05 |
| Date Added to Maude | 2016-03-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| 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 | CGN |
| Date Received | 2016-03-01 |
| Model Number | IMMULITE 2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-01 |