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 2014-11-25 for IMMULITE 2000 HOMOCYSTEINE IMMULITE 2000 CALCITONIN L2KHO manufactured by Siemens Healthcare Diagnostics (reg# 3002806944).
[20460229]
Discordant homocysteine (hcy) results were obtained on four patient samples on an immulite 2000 instrument. It is unknown if the discordant hcy results were reported to the physician(s). The customer ran quality control (qc) and patient samples on an overdue adjustment. The qc samples for two levels were out of range. It is unknown if corrected results were obtained on the same instrument or an alternate instrument or if they were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant hcy results.
Patient Sequence No: 1, Text Type: D, B5
[20569775]
A siemens customer service engineer (cse) contacted the siemens regional support center (rsc). During evaluation of the instrument data, it was discovered that the customer was running qc and patient samples on an overdue adjustment. The rsc specialist recommended that the customer perform an adjustment with a new kit lot and run patient samples after generating a valid adjustment. The rsc specialist also recommended that the customer check the accuracy and precision of the bio-rad liquicheck homocysteine control, as the customer was using a control not supported by siemens technical support. The cause of the discordant results is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2014-00701 |
| MDR Report Key | 4277551 |
| Report Source | 01,05,06 |
| Date Received | 2014-11-25 |
| Date of Report | 2014-10-31 |
| Date of Event | 2014-09-08 |
| Date Mfgr Received | 2014-10-31 |
| Date Added to Maude | 2014-12-04 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ELIZABETH BEATO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243074 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS (REG# 3002806944) |
| Manufacturer Street | GLYN RHONWY LLANBERIS, CAERNARFON |
| Manufacturer City | GWYNEDD, WALES LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 HOMOCYSTEINE |
| Generic Name | IMMULITE 2000 HOMOCYSTEINE |
| Product Code | LPS |
| Date Received | 2014-11-25 |
| Model Number | IMMULITE 2000 CALCITONIN |
| Catalog Number | L2KHO |
| Lot Number | 311 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS (REG# 3002806944) |
| Manufacturer Address | GLYN RHONWY LLANBERIS, CAERNARFON GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-25 |