MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-29 for IMMULITE 1000 IGF-1 manufactured by Siemens Healthcare Diagnostics Inc..
[39643962]
The customer contacted a siemens customer care center (ccc) specialist. A siemens designated complaint handling unit (dcu) determined that igf-1 reagent lots are kitted and validated with specific pre-treatment diluent lots. Igf-1 reagent lot 412 was kitted and validated with pre-treatment diluent lot 057. No other lot of pre-treatment diluents can be used with igf-1 reagent lot 412. The cause of incorrect usage of pre-treatment diluent lot 055 with igf-1 reagent lot 412 is due to off-label use.
Patient Sequence No: 1, Text Type: N, H10
[39643963]
The operator of an immulite 1000 instrument reported that while using insulin-like growth factor 1 (igf-1) reagent lot 412 in combination with pre-treatment diluent lot 055, it takes a long time before the igf-1 is released from binding protein 3 (bp3). The customer stated that it takes approximately 2 hours of pre-incubation before a stable igf-1 result is obtained. The customer also stated that while running tests with pre-treatment diluent lot 057 did not show this phenomenon. The customer was not reporting any patient results with reagent lot 412 and pre-treatment diluent lot 055. There are no known reports of patient intervention or adverse health consequences due to the use of incorrect combination of pre-treatment diluent lot 055 with igf-1 reagent lot 412.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2016-00109 |
| MDR Report Key | 5468503 |
| Date Received | 2016-02-29 |
| Date of Report | 2016-02-04 |
| Date of Event | 2015-11-24 |
| Date Mfgr Received | 2016-02-04 |
| Date Added to Maude | 2016-02-29 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | AZIZ AARTI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS (REG# 3002806944) |
| 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 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IMMULITE 1000 IGF-1 |
| Generic Name | IMMULITE 1000 IGF-1 |
| Product Code | CFL |
| Date Received | 2016-02-29 |
| Model Number | IMMULITE 1000 IGF-1 |
| Lot Number | 412 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | GLYN RHONWY LLANBERIS, CAERNARFON GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-29 |