MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-09 for IMMULITE 2500 INSULIN N/A 030007 manufactured by Siemens Healthcare Diagnostics.
[2447211]
Note: date of event is approximately 2-3 years ago. Falsely elevated immulite 2500 insulin results were obtained on an immulite 2500 system for one patient. This patient was put on metformin.
Patient Sequence No: 1, Text Type: D, B5
[9446867]
The physician for the patient that was put on metformin and incorrectly diagnosed as insulin sensitive, had been informed about the possibility of heterophilic antibody interference, it is believed that the patient was taken off metformin once the antibody interference was made known to the physician. As per the immulite 2500 insulin ifu, "heterophilic antibodies in human serum can react with the immunoglobulins included in the assay components causing interference with invitro immunoassays. Samples from patients routinely exposed to animals or animal serum products can demonstrate this type of interference potentially causing an anomalous result. These reagents have been formulated to minimize the risk of interference; however, potential interactions between rare sera and test components can occur. For diagnostic purposes, the results obtained from this assay should always be used in combination with the clinical examination, patient medical history, and other findings. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2011-00194 |
| MDR Report Key | 2364277 |
| Report Source | 05,06 |
| Date Received | 2011-12-09 |
| Date of Report | 2011-11-22 |
| Date Mfgr Received | 2011-11-22 |
| Date Added to Maude | 2012-07-23 |
| 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 | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | 62 FLANDERS BARTLEY ROAD |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2500 INSULIN |
| Generic Name | INSULIN |
| Product Code | CFP |
| Date Received | 2011-12-09 |
| Model Number | N/A |
| Catalog Number | 030007 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Address | GLYN RHONWY LLANBERIS CAERNAFON, GWYNEDD, WALES LL554EL UK LL55 4EL, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-09 |