MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-05-22 for IMMULITE 2000 30002 manufactured by Siemens Healthcare Diagnostics Inc..
[5817715]
Discordant sex hormone-binding globulin (shbg) and insulin-like growth factors 1 (igf-1) results were obtained on patient samples on an immulite 2000 instrument. The results were obtained while quality controls (qc) were out of range. The discordant results were reported to the physician(s). The samples were not repeated by the customer. It is unknown if the samples were repeated at any other laboratory. There are no known reports of patient intervention or adverse health consequences due to the discordant shbg and igf-1 results.
Patient Sequence No: 1, Text Type: D, B5
[13400518]
The customer contacted a siemens customer care center (ccc) specialist. Siemens investigation revealed that the customer had not been performing proper instrument maintenance. A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse discovered that the probe wash was not added to the system and that there were hairline cracks in the straws of both the probe wash bottles. The cse performed the instrument maintenance and replaced the probe wash bottles. The cse adjusted and ran quality controls, which were within the acceptable ranges. The cause of the discordant shbg and igf-1 results on patient samples is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[32603283]
The initial mdr 2247117-2015-000033 was filed on may 22, 2015. Additional/corrected information (05/22/2015): a siemens customer care center (ccc) specialist contacted the customer. The customer stated that they did not run any patient samples while the quality controls were out of range. Therefore, no discordant patient results were obtained.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2015-00033 |
| MDR Report Key | 4793040 |
| Report Source | 05,06 |
| Date Received | 2015-05-22 |
| Date of Report | 2015-01-25 |
| Date of Event | 2015-01-25 |
| Date Mfgr Received | 2015-05-22 |
| Date Added to Maude | 2015-06-22 |
| 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 2000 |
| Generic Name | IMMULITE 2000 |
| Product Code | CDZ |
| Date Received | 2015-05-22 |
| Model Number | IMMULITE 2000 |
| Catalog Number | 30002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| 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 | 2015-05-22 |