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 2013-08-28 for IMMULITE 2000 ADRENOCORTICOTROPIC HORMONE IMMULITE 2000 ADRENOCORTICOTROPIC HORMONE, PRODUCT L2KAC manufactured by Siemens Healthcare Diagnostics.
[3838005]
The customer has observed a discordant falsely elevated adrenocorticotropic hormone (acth) results on one patient sample on the immulite 2000 xpi instrument when compared to an alternate platform. The result on the same patient sample on the alternate platform was lower. The patient sample was run neat and at a 1:3 and 1:5 dilution and the results matched. The patient results were reported to the physician(s). It is unknown if the patient result obtained on the alternate platform was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant high acth result on the patient sample.
Patient Sequence No: 1, Text Type: D, B5
[10918599]
The cause of the discordant high acth results obtained on the patient sample on an immulite 2000 xpi instrument is unknown. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[26377466]
The initial mdr 2432235-2013-00417 was filed on august 28, 2013. Additional information (09/16/2013): siemens medical affairs evaluated the customer data and the following information was provided to the customer - a siemens global product support (gps) specialist contacted the customer. Gps indicated that there may be a sample heterophilic interference. The 1:3 and 1:5 dilution strength for the sample was likely not enough to dilute the interference from the heterophilic antibodies, thus a higher dilution is needed. It was also recommended to the customer that testing on an alternative method that does not have the interference is also a good method for ruling out this type of interference. Based on the information provided the customer site confirmed that they are in agreement with the feedback and that no further assistance was required. No further evaluation of this device is required. The instrument is performing according to specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2013-00417 |
| MDR Report Key | 3313973 |
| Report Source | 01,05,06 |
| Date Received | 2013-08-28 |
| Date of Report | 2013-08-06 |
| Date of Event | 2013-08-06 |
| Date Mfgr Received | 2013-09-16 |
| Date Added to Maude | 2013-11-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. MICHAEL METZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242223 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS |
| Manufacturer Street | GLYN RHONWY |
| Manufacturer City | LLANBERIS, CAERNARFON, GWYNEDD, WALES LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 ADRENOCORTICOTROPIC HORMONE |
| Generic Name | IMMULITE 2000 ADRENOCORTICOTROPIC HORMONE |
| Product Code | CKG |
| Date Received | 2013-08-28 |
| Model Number | IMMULITE 2000 ADRENOCORTICOTROPIC HORMONE, PRODUCT |
| Catalog Number | L2KAC |
| Lot Number | 253 |
| Operator | OTHER HEALTH CARE 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 CAERNARFON, GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-28 |