MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-01 for IMMULITE 2000 INSULIN L2KIN2 manufactured by Siemens Healthcare Diagnostics.
[2468536]
Discordant low insulin results were obtained for patient samples on an immulite 2000 analyzer. The customer performed a (b)(4) study with their new lot of insulin reagent (lot 314) and their prior lot of insuliln reagent (lot 308). The customer reported increased imprecision and a negative bias with insulin reagent lot 314 (compared to lot 308). There were no known reports of patient treatment being altered or prescribed due to the discordant low insulin results. There were no known reports of adverse health consequences due to the discordant low insulin results.
Patient Sequence No: 1, Text Type: D, B5
[2603754]
Discordant low insulin results were obtained for patient samples on an immulite 2000 analyzer. The customer performed a correlation study with their new lot of insulin reagent (lot 314) and their prior lot of insulin reagent (lot 308). The customer reported increased imprecision and a negative bias with insulin reagent lot 314 (compared to lot 308). There were no known reports of patient treatment being altered or prescribed due to the discordant low insulin results. There were no known reports of adverse health consequences due to the discordant low insulin results.
Patient Sequence No: 1, Text Type: D, B5
[9593132]
The customer contacted the siemens technical solutions center (tsc) about the discordant low insulin results with lot 314. The cause of the discordant low insulin results is unknown at this time. This incident is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[9837312]
Siemens filed the initial mdr on 02/01/2012. 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
[9959080]
The customer contacted the siemens technical solutions center (tsc) about the discordant low insulin results with lot 314. The cause of the discordant low insulin results is unknown at this time. This incident is currently under investigation. (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 the concentration of the insulin bead coat antibody (raw material). The device is running within specifications. No further evaluation of the device is necessary.
Patient Sequence No: 1, Text Type: N, H10
[10060003]
The 510(k) number has been corrected: k022603.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00028 |
| MDR Report Key | 2435600 |
| Report Source | 05,06 |
| Date Received | 2012-02-01 |
| Date of Report | 2012-01-05 |
| Date of Event | 2012-01-05 |
| 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 INSULIN |
| Generic Name | INSULIN ASSAY |
| Product Code | CFP |
| Date Received | 2012-02-01 |
| Model Number | IMMULITE 2000 INSULIN |
| Catalog Number | L2KIN2 |
| Lot Number | 314 |
| 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 GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-01 |