MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-11-20 for IMMULITE 2000 IGF-1 L2KGF manufactured by Siemens Healthcare Diagnostics.
[3043710]
The laboratory evaluated their data from the past three years for insulin-like growth factor (igf-1) on an immulite 2000 instrument and stated that there had been an overall positive shift. There was a shift of approximately nine percent in (b)(6) 2010 when the customer began using lot 450. A second shift, of approximately seven percent, occurred in (b)(6) 2011 when the customer began using lot 470. There were no reports of patient intervention or adverse health consequences due to the discordant igf-1 results.
Patient Sequence No: 1, Text Type: D, B5
[10322270]
The cause of the increase in abnormal results for igf-1 is unknown. An urgent medical device correction (umdc), umdc 2012-11-13 - "immulite / immulite 1000 / immulite 2000 / immulite 2000 xpi all immulite platforms for igf-i shift in patient medians and supply disruption" was sent to customers in november 2012. Siemens is investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
[10463920]
The initial mdr 2432235-2012-00390 was filed on november 20, 2012. (b)(4): additional information: the corrections and removal report (crr) was filed with the fda on november 28, 2012. The crr number is 2432235-11/28/2012-007-c.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00390 |
| MDR Report Key | 2840857 |
| Report Source | 05,06 |
| Date Received | 2012-11-20 |
| Date of Report | 2012-10-22 |
| Date of Event | 2012-08-10 |
| Date Mfgr Received | 2012-11-28 |
| Date Added to Maude | 2013-02-26 |
| 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 | MINDY LOSAPIO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242312 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | GLYN RHONWY LLANBERIS, CAERNARFON |
| Manufacturer City | GWYNEDD, WALES LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-11/28/2012-007-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 IGF-1 |
| Generic Name | IMMULITE 2000 |
| Product Code | CFL |
| Date Received | 2012-11-20 |
| Model Number | IMMULITE 2000 IGF-1 |
| Catalog Number | L2KGF |
| Lot Number | 450; 470 |
| 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 |
| Manufacturer Address | GLYN RHONWY LLANBERIS, CAERNARFON GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-20 |