MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-11-20 for IMMULITE 30001 manufactured by Siemens Healthcare Diagnostics Inc..
[5227731]
Patient samples from one intraoperative patient were delayed from testing with the turbo intact parathyroid hormone (turbo ipth) method on an immulite instrument. The patient was in surgery when the samples were received by the laboratory. The operator was unable to run the samples on the immulite instrument, which did not have power running to it. The samples were then run on an immulite 2000 instrument, but the amount of time needed to obtain results was longer. The patient was under anesthesia for an additional hour due to the delay in obtaining results. The operator spoke to the physician and verified that there were no adverse health consequences for the patient.
Patient Sequence No: 1, Text Type: D, B5
[12496327]
A siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument, the cse discovered that the power supply was not operational. The cse installed a new power supply and verified the instrument was operational. The cause of the delay in obtaining ipth results for an intraoperative patient was a malfunction of the power supply. 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 | 2247117-2014-00082 |
| MDR Report Key | 4266434 |
| Report Source | 05,06 |
| Date Received | 2014-11-20 |
| Date of Report | 2014-11-06 |
| Date of Event | 2014-11-06 |
| Date Mfgr Received | 2014-11-06 |
| Date Added to Maude | 2014-12-02 |
| 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 | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVE |
| 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 RD |
| 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 | IMMUNOASSAY ANALYZER |
| Product Code | JJQ |
| Date Received | 2014-11-20 |
| Model Number | IMMULITE |
| Catalog Number | 30001 |
| 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 | 2014-11-20 |