MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-02-07 for IMMULITE 2000 ACTH N/A L2KAC2 manufactured by Siemens Healthcare Diagnostics.
[19929526]
Discordant immulite 2000 acth results were generated on one patient sample. The laboratory repeated the sample and the repeat results confirmed patient value from previous month. A corrected report was sent to the physician. A second sample was also found to be low, it was repeated and a corrected report sent out. There was no known report of treatment given or withheld based on the discordant acth results.
Patient Sequence No: 1, Text Type: D, B5
[20278813]
A siemens fse (field service engineer) was dispatched and contacted the customer. The customer declined service as they stated that the discordant results were due to a sample mixing issue. The instrument is performing within specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2012-00033 |
| MDR Report Key | 2441445 |
| Report Source | 05,06 |
| Date Received | 2012-02-07 |
| Date of Report | 2012-01-13 |
| Date of Event | 2012-01-13 |
| Date Mfgr Received | 2012-01-13 |
| Date Added to Maude | 2012-08-14 |
| 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 | GLYN RHONWY LLANBERIS |
| Manufacturer City | CAERNAFON, 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 ACTH |
| Generic Name | ACTH IMMUNO-ASSAY |
| Product Code | CKG |
| Date Received | 2012-02-07 |
| Model Number | N/A |
| Catalog Number | L2KAC2 |
| Lot Number | 243/241 |
| 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 LANNBERIS CAERNAFON, GWYNEDD,, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-02-07 |