MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-09-23 for IMMULITE/IMMULITE 1000 CORTISOL LKCO manufactured by Siemens Healthcare Diagnostics Products Limited.
[4940443]
The customer has observed high bias results on two levels for biorad quality control samples when using the cortisol assay reagent lot 382 on an immulite 1000 system. The data obtained was either outside or at the upper limit of the acceptable range. The customer did not report any patient sample data. There are no known reports of patient intervention or adverse health consequences due to the high bias observed on the biorad quality control samples.
Patient Sequence No: 1, Text Type: D, B5
[12372309]
Siemens has confirmed that immulite/immulite 1000 cortisol kit lots 381, 382, and 383 demonstrate a positive bias with patient samples in the range of approximately 13% to 40%. The positive bias was also observed in quality control materials and may result in values outside the established ranges. The issue has been resolved with immulite/immulite 1000 cortisol kit lots 384 and above. An urgent medical device recall umdr2014-09-19 was sent to us customers and an urgent field safety notice (ufsn) 1111, was sent to ous customers in september of 2014. The umdr and ufsn state that customers are requested to discontinue use of and discard the immulite/immulite 1000 cortisol kits listed, and to review the umdr/ufsn with their medical director.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2014-00550 |
| MDR Report Key | 4111338 |
| Report Source | 01,05,06 |
| Date Received | 2014-09-23 |
| Date of Report | 2014-09-12 |
| Date of Event | 2014-05-01 |
| Date Mfgr Received | 2014-09-12 |
| Date Added to Maude | 2014-10-02 |
| 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. ELIZABETH BEATO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243074 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED |
| Manufacturer Street | REGISTRATION #3002806944 GLYN RHONWY |
| Manufacturer City | LLANBERIS, CAERNARFON, GWYNEDD, WALES LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-09/22/14-003R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE/IMMULITE 1000 CORTISOL |
| Generic Name | IMMULITE/IMMULITE 1000 CORTISOL |
| Product Code | CGR |
| Date Received | 2014-09-23 |
| Model Number | IMMULITE/IMMULITE 1000 CORTISOL |
| Catalog Number | LKCO |
| Lot Number | 382 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED |
| Manufacturer Address | GLYN RHONWY LLANBERIS CAERNARFON, GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-23 |