MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-02-27 for IMMULITE manufactured by Siemens Healthcare Diagnostics Inc..
[68418454]
The customer contacted a siemens customer care specialist (ccc). The ccc offered service to check the instrument, but the customer declined as they did not have an active contract on the system. The ccc remotely confirmed that all instrument maintenance was current and that no mechanical errors were posted on the event log at the time of testing. The ccc checked the adjustment data that was used to generate the < 5 iu/ml result, as well as the quality control results from the system. The adjustment parameters and the quality control results were within range. The cause of the discordant, false negative rubella igg result 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
[68418475]
A discordant, false negative rubella igg result was obtained on one patient sample on an immulite instrument. It is unknown if the initial result was reported to the physician(s). Five days later, the initial sample was tested in duplicate on the same instrument and same reagent lot, resulting positive. The patient was then re-drawn a few days later and this re-draw sample resulted positive. The re-draw sample was also sent to a reference laboratory where it resulted positive as well. It is unknown if the repeat results were reported to the physician(s). There are no known reports of patient intervention due to the false negative rubella igg result. There are no known reports of a delay in administering treatment or medical intervention to the patient due to the false negative rubella igg result.
Patient Sequence No: 1, Text Type: D, B5
[69789701]
The initial mdr 2247117-2017-00025 was filed on february 27, 2017. Additional information (03/07/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided by the customer and stated that the adjustment and control data were normal. The cause of the event could not be determined, but the customer may have accidentally tested the wrong sample initially. Based on the available information, immulite rubella quantitative igg lot 0336 is performing as intended. The cause of the discordant, false negative rubella igg result is unknown. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2017-00025 |
| MDR Report Key | 6360715 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-27 |
| Date of Report | 2017-03-07 |
| Date of Event | 2017-02-14 |
| Date Mfgr Received | 2017-03-07 |
| Date Added to Maude | 2017-02-27 |
| 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 | DEVYANI CHAUDHURI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242637 |
| 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 |
| Generic Name | IMMULITE |
| Product Code | LFX |
| Date Received | 2017-02-27 |
| Model Number | IMMULITE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 |
| Brand Name | IMMULITE |
| Generic Name | IMMULITE |
| Product Code | JJQ |
| Date Received | 2017-02-27 |
| Model Number | IMMULITE |
| Operator | HEALTH 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 INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY RD. FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-27 |