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 L2KGF2 manufactured by Siemens Healthcare Diagnostics.
[3047890]
An high incidence rate of falsely elevated patient results was observed for insulin-like growth factor (igf-1) on the immulite 2000 instrument. The customer reported that the laboratory had been using a different company's igf-1 assay, and physicians had expressed concern about the quantity of high patient results. The rate of falsely elevated results had increased from ten percent to twenty-four percent. The laboratory performed a comparison study between the igf-1 assay in use and the immulite 2000 igf-1 assay, and discovered the same high bias. 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
[10321094]
The cause of the increase in abnormal results for igf-1 is unknown. An urgent medical device correction (umdc), (b)(4) - "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 (b)(4) 2012. Siemens is investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
[10463918]
The initial mdr 2432235-2012-00383 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 | 2432235-2012-00383 |
| MDR Report Key | 2839837 |
| Report Source | 05,06 |
| Date Received | 2012-11-20 |
| Date of Report | 2012-10-23 |
| Date of Event | 2012-10-23 |
| 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 | L2KGF2 |
| 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 |