MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-01-23 for IMMULITE 2000 IMMULITE 2000 INSULIN manufactured by Siemens Healthcare Diagnostics, Inc..
[2424440]
Precision issues with immulite 2000 insulin lot#314 were observed by the customer during lot to lot validation and calibration. No patient samples were tested, therefore there are no reports of adverse health consequences or patient intervention.
Patient Sequence No: 1, Text Type: D, B5
[9530852]
The cause of the immulite insulin imprecision is unknown at this time. This incident is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[10113843]
The 510(k) number has been corrected: k022603.
Patient Sequence No: 1, Text Type: N, H10
[18052133]
Siemens filed the initial mdr on 01/23/2012. Siemens healthcare dx has implemented a field correction (urgent device recall ur005-2012-04-26, april 2012) for the immulite 2000/2000 xpi insulin assay lots 312-316.
Patient Sequence No: 1, Text Type: N, H10
[20917033]
Precision issues with immulite 2000 insulin lot#314 were observed by the customer during lot to lot validation and calibration. No patient samples were tested, therefore there are no reports of adverse health consequences or patient intervention. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[21208724]
(b)(4) 2012 additional information:the immulite 2000 insulin imprecision on lot#314 has been investigated by siemens. Siemens has determined that the cause of the immulite 2000 insulin imprecision on lot# 314 is due to a reduction in theconcentration of the insulin bead coat antibody (raw material). Siemens became aware of the additional information on 03/28/2012. The device is runing within specification. No further evaluation of the device is necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00017 |
| MDR Report Key | 2424697 |
| Report Source | 05,06 |
| Date Received | 2012-01-23 |
| Date of Report | 2011-12-30 |
| Date of Event | 2011-12-30 |
| Date Mfgr Received | 2012-06-07 |
| Date Added to Maude | 2012-07-31 |
| 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 | LORIANN RUSSO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242287 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | GLYN RHONWY LLANBERIS |
| Manufacturer City | CAERNATION, GWYNEDD, WALES LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | UR005-2012-04-26 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMULITE 2000 |
| Product Code | CFP |
| Date Received | 2012-01-23 |
| Model Number | IMMULITE 2000 INSULIN |
| Lot Number | 314 |
| ID Number | N/A |
| 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, INC. |
| Manufacturer Address | LLANBERIS GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-23 |