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 2017-12-20 for IMMULITE 2000 manufactured by Siemens Healthcare Diagnostics Inc..
[96045065]
A siemens customer service engineer (cse) was dispatched to the customer site. The cse verified proper functioning of the waste vacuum pressure, sample and reagent diluter positions, and instrument voltages. The cse proactively replaced the sample and reagent probes, verified the sample and reagent probe positions and angles, and readjusted the wash spinner speed. The cse performed a watertest pm and passed testing. A headquarter support center (hsc) specialist reviewed the instrument data and found no sample level sense issues or reagent level sense issues, and no mechanical issues were recorded during the time the discordant result occurred. The cause of the discordant, low patient ipth result on one patient sample is unknown. The instrument is performing within manufacturing specifications. The customer has run quality controls (qc) and patients samples with no issues. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[96045066]
A single intact parathyroid hormone (ipth) discordant low patient result was obtained on the immulite 2000 instrument on (b)(6) 2017. The discordant result was reported to the healthcare practitioner who questioned the result. The operator sent the same sample to a reference lab, as per physician's request, for repeat testing on (b)(6) 2017. The repeated patient sample resulted high and in line with the physician's expectations for the patient. There are no reports of patient intervention or adverse health consequence due to the discordant, low patient ipth result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2017-00139 |
| MDR Report Key | 7133696 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-20 |
| Date of Report | 2017-12-20 |
| Date of Event | 2017-11-20 |
| Date Mfgr Received | 2017-11-29 |
| Date Added to Maude | 2017-12-20 |
| 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 | ROLANDO HUALPA |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN, NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242963 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY RD REGISTRATION #: 2247117 |
| 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 | CEW |
| Date Received | 2017-12-20 |
| 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 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMULITE 2000 |
| Product Code | JJQ |
| Date Received | 2017-12-20 |
| Model Number | IMMULITE 2000 |
| Operator | HEALTH 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 RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-20 |