MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-12-10 for IMMULITE 2000 IGF-1 L2KGF manufactured by Siemens Healthcare Diagnostics.
[18526286]
The customer states that they have observed positive bias with the insulin-like growth factor (igf-1) assay on kit lots 486 and 487. 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
[18754078]
The cause of the increase in abnormal results for igf-1 is unknown. An urgent field safety notice (ufsn), ufsn 4005 - "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. New date of awareness: during a lookback of pmdrs related to the igf-1 bias field correction, this complaint was identifiedas belonging to the issue addressed in the field correction. On 11/09/2012, the decision to issue a ufsn (ufsn 4005) was made due to a positive shift in patient medians of approximately 20% which occurred between late 2009 and mid 2011. The performance of the kit lots currently in distribution is in alignment with the reference range data published in the instructions for use (ifu).
Patient Sequence No: 1, Text Type: N, H10
[19059509]
The initial mdr 2432235-2012-00424 was filed on (b)(4) 2012. (b)(4) 2012: additional information: the corrections and removal report (crr) was filed with the fda on (b)(6) 2012. The crr number is 2432235-11/28/2012-007-c.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00424 |
| MDR Report Key | 2864186 |
| Report Source | 05,06 |
| Date Received | 2012-12-10 |
| Date of Report | 2012-11-09 |
| Date of Event | 2012-09-13 |
| Date Mfgr Received | 2012-11-28 |
| Date Added to Maude | 2013-03-14 |
| 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 | 2012-12-10 |
| Model Number | IMMULITE 2000 IGF-1 |
| Catalog Number | L2KGF |
| Lot Number | 486; 487 |
| 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 | 2012-12-10 |