MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-31 for IMMULITE 2000 XPI 030001-03 manufactured by Siemens Healthcare Diagnostics Inc..
[24646487]
The customer contacted siemens customer care center (ccc) for this event. Siemens ccc requested patient sample results and instrument files for further investigation from the customer. The customer has not provided siemens healthcare diagnostics any information to date. The cause of the discordant results for igf-1 on the immulite 2000 xpi instrument is unknown.
Patient Sequence No: 1, Text Type: N, H10
[24646548]
The customer has obtained discordant results on seven patient samples for the insulin-like growth factor1 (igf-1) assay on an immulite 2000 xpi instrument. It is unknown if any of the results were reported to physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant results on the patient samples.
Patient Sequence No: 1, Text Type: D, B5
[40187424]
The customer contacted siemens diagnostics on (b)(6) 2015 and requested that a siemens field service engineer (fse) visit the customer site and evaluate the immulite 2000 xpi instrument. The fse performed a routine preventive maintenance on the immulite 2000 xpi system. The customer repeated the samples on the immulite 2000 xpi system as indicated after the fse visit, and the results were acceptable and within expectations. The customer has had no other issues with the system. The cause of the discordant igf-1 results on the patient samples is unknown. The system is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[40187465]
The customer obtained discordant results on patient samples for insulin-like growth factor-1 (igf-1) on an immulite 2000 xpi instrument. On (b)(6) 2015 eleven patient samples were analyzed on the immulite 2000 xpi instrument using igf-1 reagent lot 534. On (b)(6) 2015 eight different patient samples were analyzed on the same instrument using the same reagent lot. On (b)(6) 2015 the customer adjusted a new lot of igf-1 reagent lot 536 on the immulite 2000 xpi instrument, and carried out a correlation study using the same patient samples between reagent lots 534 and 536. It was observed that the results on the patient samples were higher when using reagent lot 536. As a result the customer re-ran four of the eleven patient samples (the other seven samples were not available for retesting) from the first run and all eight samples from the second run using reagent lot 534. The results were higher and matched the results obtained on the patient samples when using reagent lot 536. All results obtained on patient samples using both igf-1 reagent lots were reported to the physician(s). There were no reports of adverse health consequences due to the discordant results obtained on the patient samples for igf-1
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2015-00043 |
| MDR Report Key | 4956925 |
| Date Received | 2015-07-31 |
| Date of Report | 2015-07-15 |
| Date of Event | 2015-06-15 |
| Date Mfgr Received | 2015-08-05 |
| Date Added to Maude | 2015-07-31 |
| 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 | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | 511 BENEDIT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 10591 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 XPI |
| Generic Name | IMMULITE 2000 XPI |
| Product Code | OAM |
| Date Received | 2015-07-31 |
| Model Number | IMMULITE 2000 XPI |
| Catalog Number | 030001-03 |
| Operator | OTHER HEALTH CARE 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 ROAD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-31 |