MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-02 for IMMULITE 2000 IMMULITE 2000 INSULIN manufactured by Siemens Healthcare Diagnostics, Inc..
[2469033]
Patient samples were run in duplicate on both the immulite 2500xpi (using insulin lot# 193) and the immulite 2000 (using insulin lot#308). Results from both systems were compared and precision issues with immulite 2000 insulin lot#308 were observed. No results were reported to the physician. There are no reports of adverse health consequences or patient intervention due to the insulin results.
Patient Sequence No: 1, Text Type: D, B5
[9587763]
The immulite 2000 insulin imprecision is unknown at this time. This incident is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[10060468]
The 510(k) number has been corrected: k022603.
Patient Sequence No: 1, Text Type: N, H10
[16726299]
Patient samples were run in duplicate on both the immulite 2500xpi (using insulin lot# 193) and the immulite 2000 (using insulin lot#308). Results from both systems were compared and precision issues with immulite 2000 insulin lot#308 were observed. No results were reported to the physician. There are no reports of adverse health consequences or patient intervention due to the insulin results.
Patient Sequence No: 1, Text Type: D, B5
[16997553]
(b)(4) 2012 additional information:the immulite 2000 insulin imprecision on lot#308 has been investigated by siemens. Siemens has determined that the cause of the immulite 2000 insulin imprecision on lot# 308 is due to a reduction in the concentration of the insulin bead coat antibody (raw material). Siemens became aware of the additional information on 03/28/2012. The device is runing within specification. No further evaluation of the device is necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00018 |
| MDR Report Key | 2436074 |
| Report Source | 05,06 |
| Date Received | 2012-02-02 |
| Date of Report | 2012-01-06 |
| Date of Event | 2011-09-26 |
| Date Mfgr Received | 2012-06-07 |
| Date Added to Maude | 2012-07-31 |
| 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 | LORIANN RUSSO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242287 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | GLYN RHONWY LLANBERIS |
| Manufacturer City | CAERNATION, 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 |
| Generic Name | IMMULITE 2000 |
| Product Code | CFP |
| Date Received | 2012-02-02 |
| Model Number | IMMULITE 2000 INSULIN |
| Lot Number | 308 |
| ID Number | N/A |
| 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 | LLANBERIS GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-02 |