MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-23 for IMMULITE 2000 IGF-1 N/A L2KGF manufactured by Siemens Healthcare Diagnostics.
[2929169]
Customer noticed increased rate of elevated patient results for patient samples using the igf-1 method on the immulite 2000 xpi system. The endocrinologists are performing an increased number of ggt suppression tests with growth hormones to exclude acromegaly. There was no known report of treatment given or withheld based on the igf-1 results.
Patient Sequence No: 1, Text Type: D, B5
[10033852]
Siemens is currently investigating this issue.
Patient Sequence No: 1, Text Type: N, H10
[10341272]
(b)(4): additional information: an urgent field safety notice (ufsn), (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.
Patient Sequence No: 1, Text Type: N, H10
[10497236]
The initial mdr 2432235-2012-00251 was filed on (b)(4), 2012. The first follow-up mdr 2432235-2012-00251_s1 was filed on (b)(4), 2012. (b)(4) 2012: additional information: the corrections and removal report (crr) was filed with the fda on (b)(4), 2012. The crr number is 2432235-11/28/2012-007-c. Mdr 2432235-2012-00251_s1 states that the patient gender was female. The patient gender is unknown.
Patient Sequence No: 1, Text Type: N, H10
[26377310]
Corrected information (10/3/2013): upon review of the supplemental mdr 2432235-2013-00251_s2 it was noted that the initial mdr number was entered incorrectly. The correct number is 2432235-2012-00251. In addition the follow up mdr number 2432235-2013-00251_s2 was entered incorrectly in the manufacturer report number section (mfr report #). The corrected number is 2432235-2012-00251_s2.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00251 |
| MDR Report Key | 2711273 |
| Report Source | 05,06 |
| Date Received | 2012-08-23 |
| Date of Report | 2012-06-08 |
| Date of Event | 2012-06-07 |
| Date Mfgr Received | 2013-10-03 |
| Date Added to Maude | 2012-12-10 |
| 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 | MS. 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 |
| Manufacturer City | CAERNARFON, 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 | IGF-1 IMMUNO-ASSAY |
| Product Code | CFL |
| Date Received | 2012-08-23 |
| Model Number | N/A |
| Catalog Number | L2KGF |
| Lot Number | 462, 465, 471, 472, 473 |
| 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 LANNBERIS CAERNARFON, GWYNEDD,, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-23 |