MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-04-27 for IMMULITE 30001 manufactured by Siemens Healthcare Diagnostics Inc..
[5586075]
The operator of an immulite instrument was running adjustments on a new kit for the turbo intact parathyroid hormone (ipth) assay when they encountered an error message. Subsequently, five ipth samples from a patient in surgery needed to be tested in another laboratory, causing a delay in obtaining sample results. The patient was under the influence of anesthesia for a longer time than expected. There are no known reports of patient intervention or adverse consequences due to the delay in obtaining ipth results.
Patient Sequence No: 1, Text Type: D, B5
[13154894]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. The cse evaluated the instrument and discovered that the sample bar code reader was operating intermittently. The cse adjusted the speed and the voltage of the bar code reader. On a subsequent visit the cse replaced the substrate heater printed circuit board. Diagnostics and quality controls were run and were within appropriate ranges. The cause of the failing assay adjustment was related to a malfunction of the barcode reader. The instrument is performing according to the specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2015-00025 |
| MDR Report Key | 4731780 |
| Report Source | 05,06 |
| Date Received | 2015-04-27 |
| Date of Report | 2015-04-02 |
| Date of Event | 2015-04-02 |
| Date Mfgr Received | 2015-04-02 |
| Date Added to Maude | 2015-05-28 |
| 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 | MR. MICHAEL METZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242223 |
| 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 | JJQ |
| Date Received | 2015-04-27 |
| Model Number | IMMULITE |
| Catalog Number | 30001 |
| 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 | 2015-04-27 |